Safety drug handling device

ABSTRACT

A drug mixing system including at least one receptacle port adaptor adapted to be inserted into a port of a fluid receptacle, at least one syringe adaptor adapted to be attached to a syringe and to the at least one receptacle port adaptor and at least one vial adaptor adapted for connection to a vial containing a drug and adapted for connection to the at least one syringe adaptor, the system being characterized in that at least one of the receptacle port adaptor, the at least one syringe adaptor and the at least one vial adaptor being vented to the atmosphere in a manner which prevents release to the atmosphere of possibly harmful contents of the vial in a liquid, solid or gaseous form.

REFERENCE TO RELATED APPLICATION

The present application is related to and claims priority from thefollowing pending patent applications, the disclosure of which is herebyincorporated by reference:

U.S. Provisional Patent Application No. 60/516,613 filed Oct. 30, 2003.

FIELD OF THE INVENTION

The present invention relates to drug mixing systems generally.

BACKGROUND OF THE INVENTION

The following U.S. patents and non-U.S. patent publications are believedto represents the current state of the art:

U.S. Pat. Nos. 6,221,041; 6,715,520; 6,409,708; PCT US02/40596; WO2004004806 ; WO 03086529; WO 9819724; WO 03/086530; WO 0035517 and WO0211794.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved drug mixing system,operative for use with a luer fitted hypodermic syringe, which isparticularly useful in handling toxic drugs such as antineoplasticdrugs.

There is thus provided in accordance with a preferred embodiment of thepresent invention a drug mixing system including at least one receptacleport adaptor adapted to be inserted into a port of a fluid receptacle,at least one vial adaptor adapted for connection to a vial containing adrug and at least one syringe adaptor adapted to be attached to asyringe and to at least one of the at least one receptacle port adaptorand the at least one vial adaptor, the system being characterized inthat at least one of the at least one receptacle port adaptor, the atleast one syringe adaptor and the at least one vial adaptor being ventedto the atmosphere in a manner which prevents release to the atmosphereof possibly harmful contents of the vial in a liquid, solid or gaseousform.

There is also provided in accordance with another preferred embodimentof the present invention a drug mixing system including at least onereceptacle port adaptor adapted to be inserted into a port of a fluidreceptacle, at least one vial adaptor adapted for connection to a vialcontaining a drug and at least one syringe adaptor adapted to beattached to a syringe and to at least one of the at least one receptacleport adaptor and the at least one vial adaptor, the system beingcharacterized in that the at least one vial adaptor being vented to theatmosphere in a manner which prevents release to the atmosphere ofpossibly harmful contents of the vial.

Preferably, the drug mixing system also includes a membrane ventoperative to vent at least one of the at least one receptacle portadaptor, the at least one syringe adaptor and the at least one vialadaptor to the atmosphere. Additionally, the membrane vent includes afilter. Additionally or alternatively, the membrane vent includes ahydrophobic membrane.

There is also provided in accordance with another preferred embodimentof the present invention a drug mixing system including at least onereceptacle port adaptor adapted to be inserted into a port of a fluidreceptacle, at least one vial adaptor adapted for connection to a vialcontaining a drug and at least one syringe adaptor adapted to beattached to a syringe and to at least one of the at least one receptacleport adaptor and the at least one vial adaptor, the system beingcharacterized in that the at least one syringe adaptor is adapted to bebrought into fluid communication and mechanically locked to at least oneof the at least one receptacle port adaptor and the at least one vialadaptor in a single step.

Preferably, at least one of the at least one vial adaptor, the at leastone receptacle port adaptor and the at least one syringe adaptor arevented to the atmosphere without permitting potentially harmful contentsof the vial to reach the atmosphere.

Preferably, the drug mixing system also includes a stopcock connected tothe at least one vial adaptor and to the at least one receptacle portadaptor.

There is further provided in accordance with yet another preferredembodiment of the present invention a drug mixing system including atleast one receptacle port adaptor adapted to be inserted into a port ofa fluid receptacle and at least one vial adaptor adapted for connectionto a vial containing a drug and connected to the at least one receptacleport adaptor, the system being characterized in that at least one of theat least one receptacle port adaptor and the at least one vial adaptoris vented to the atmosphere in a manner which prevents release to theatmosphere of possibly harmful contents of the vial.

There is even further provided in accordance with still anotherpreferred embodiment of the present invention a drug mixing systemincluding at least one receptacle port adaptor adapted to be insertedinto a port of a fluid receptacle and at least one vial adaptor adaptedfor connection to a vial containing a drug and connected to the at leastone receptacle port adaptor, the at least one vial adaptor including aventing and sealing element, operative to allow air into the drug mixingsystem and adapted to prevent air from escaping from the drug mixingsystem.

Preferably, the venting and sealing element includes a hydrophobicmembrane and a narrow bore.

Preferably, the narrow bore is irreversibly filled with liquid upon flowof liquid from the fluid receptacle to the vial, thus preventing airfrom escaping.

Alternatively or additionally, the receptacle port adaptor includes anelastomer covered needle and the receptacle port adaptor and the vialadaptor are integrally formed. Alternatively, the receptacle portadaptor includes an elastomer covered needle and the receptacle portadaptor, the syringe adaptor and the vial adaptor are integrally formed.

Preferably, the at least one vial adaptor also includes a protectivevial housing operative to prevent release to the atmosphere of possiblyharmful contents of the vial in a liquid, solid or gaseous form in theevent of breakage of the vial.

In another preferred embodiment, the fluid receptacle includes a spikeport and the at least one receptacle port adaptor includes a spike portadaptor. Additionally or alternatively, the fluid receptacle includes aneedle port and the at least one receptacle port adaptor includes aneedle port adaptor. Additionally, the needle port adaptor includes aneedle, the needle being protected by a needle protector. Preferably,the needle protector includes a latex needle cover.

Preferably, the drug mixing system also includes a vial head adaptoradapted for connection between the vial adaptor and the vial.

In another preferred embodiment, the at least one receptacle portadaptor and the fluid receptacle are adapted to be connected to anintravenous cannula on a patient via an intravenous infusion set.

Preferably, the at least one syringe adaptor and the syringe are adaptedto be connected to an intravenous cannula on a patient via anintravenous infusion set using an infusion set adaptor. Additionally oralternatively, the syringe adaptor is covered by a syringe coverelement.

There is yet further provided in accordance with another preferredembodiment of the present invention a drug mixing system including atleast one drug mixing element including atmospheric ventingfunctionality, characterized in that it prevents potentially harmfuldrug material from being released to the atmosphere via the ventingfunctionality, the potentially harmful drug material including at leastone of solid, liquid, gas and aerosol.

There is even further provided in accordance with yet another preferredembodiment of the present invention a drug mixing method includingattaching a luer fitted hypodermic syringe having a plunger to a syringeadaptor, inserting a receptacle port adaptor into a port in a receptaclecontaining a fluid, attaching the syringe adaptor, having the syringeattached thereto, to the receptacle port adaptor, retracting theplunger, thereby at least partially filling the syringe with fluid drawnfrom the receptacle in a manner which ensures that the fluid remainssterile and that a user is not exposed to the fluid, connecting thesyringe adaptor having the syringe attached thereto, to a vial adaptorassembly, having a drug containing vial attached thereto, pushing theplunger, thus injecting the fluid contained in the syringe into the drugcontaining vial, thereby producing a drug solution in the vial andretracting the plunger, thus drawing at least part of the contents ofthe vial into the syringe, wherein at least one of the receptacle portadaptor, the syringe adaptor and the vial adaptor being vented to theatmosphere in a manner which prevents release to the atmosphere ofpossibly harmful contents of the vial in a liquid, solid or gaseousform.

There is still further provided in accordance with yet another preferredembodiment of the present invention a drug mixing method includingattaching a luer fitted hypodermic syringe having a plunger to a syringeadaptor, inserting a receptacle port adaptor into a port in a receptaclecontaining a fluid, attaching the syringe adaptor, having the syringeattached thereto, to the receptacle port adaptor, retracting theplunger, thereby at least partially filling the syringe with fluid drawnfrom the receptacle in a manner which ensures that the fluid remainssterile and that a user is not exposed to the fluid, connecting thesyringe adaptor having the syringe attached thereto, to a vial adaptorassembly, having a drug containing vial attached thereto, pushing theplunger, thus injecting the fluid contained in the syringe into the drugcontaining vial, thereby producing a drug solution in the vial andretracting the plunger, thus drawing at least part of the contents ofthe vial into the syringe, wherein the syringe adaptor is adapted to bebrought into fluid communication and mechanically locked to at least oneof the receptacle port adaptor and the vial adaptor in a single step.

There is yet further provided in accordance with another preferredembodiment of the present invention a drug mixing method includingattaching a luer fitted hypodermic syringe having a plunger to a syringeadaptor, inserting a receptacle port adaptor into a port in a receptaclecontaining a fluid, connecting the syringe adaptor having the syringeattached thereto, to a vial adaptor assembly, having a drug containingvial attached thereto, retracting the plunger, thus drawing at leastpart of the contents of the vial into the syringe, connecting thesyringe adaptor having the syringe attached thereto, to the receptacleport adaptor and pushing the plunger, thus injecting the at least partof the contents of the vial into the receptacle, wherein at least one ofthe receptacle port adaptor, the syringe adaptor and the vial adaptor isvented to the atmosphere in a manner which prevents release to theatmosphere of possibly harmful contents of the vial in a liquid, solidor gaseous form.

There is still further provided in accordance with yet another preferredembodiment of the present invention a drug mixing method includingattaching a luer fitted hypodermic syringe having a plunger to a syringeadaptor, inserting a receptacle port adaptor into a port in a receptaclecontaining a fluid, connecting the syringe adaptor having the syringeattached thereto, to a vial adaptor assembly, having a drug containingvial attached thereto, retracting the plunger, thus drawing at leastpart of the contents of the vial into the syringe, connecting thesyringe adaptor having the syringe attached thereto, to the receptacleport adaptor and pushing the plunger, thus injecting the at least partof the contents of the vial into the receptacle, wherein the syringeadaptor is adapted to be brought into fluid communication andmechanically locked to at least one of the receptacle port adaptor andthe vial adaptor in a single step.

There is even further provided in accordance with another preferredembodiment of the present invention a drug mixing method includingattaching a luer fitted hypodermic syringe having a plunger to a syringeadaptor, connecting the syringe adaptor having the syringe attachedthereto, to a vial adaptor assembly, having a drug containing vialattached thereto, retracting the plunger, thus drawing at least part ofthe contents of the vial into the syringe and pushing the plunger, thusinjecting the at least part of the contents of the vial into an infusionline, wherein at least one of the receptacle port adaptor, the syringeadaptor and the vial adaptor is vented to the atmosphere in a mannerwhich prevents release to the atmosphere of possibly harmful contents ofthe vial in a liquid, solid or gaseous form.

There is still further provided in accordance with yet another preferredembodiment of the present invention a drug mixing method includingattaching a luer fitted hypodermic syringe having a plunger to a syringeadaptor, connecting the syringe adaptor having the syringe attachedthereto, to a vial adaptor assembly, having a drug containing vialattached thereto, retracting the plunger, thus drawing at least part ofthe contents of the vial into the syringe and pushing the plunger, thusinjecting the at least part of the contents of the vial into an infusionline, wherein the syringe adaptor is adapted to be brought into fluidcommunication and mechanically locked to at least one of the receptacleport adaptor and the vial adaptor in a single step.

Preferably, the connecting the syringe adaptor also includesdisconnecting the syringe adaptor from the receptacle adaptor prior tothe connecting.

Preferably, the connecting the syringe adaptor having the syringeattached thereto to the receptacle port adaptor also includesdisconnecting the syringe adaptor from the vial adaptor prior to theconnecting.

Additionally or alternatively, the connecting the syringe adaptorincludes connecting the drug containing vial to a vial head adaptor andconnecting the drug containing vial having the vial head adaptorattached thereto to the vial adaptor assembly, prior to the connectingthe syringe to the vial adaptor assembly. Alternatively or additionally,the drug mixing method also includes attaching the syringe adaptor,having the syringe containing at least part of the drug solutionattached thereto, to the receptacle port adaptor and injecting contentsof the syringe into the receptacle.

There is still further provided in accordance with still anotherpreferred embodiment of the present invention a drug mixing methodincluding inserting a receptacle port adaptor into a port in areceptacle containing a fluid, connecting a drug containing vial to thereceptacle port adaptor, transferring at least a portion of the fluidfrom the receptacle to the drug containing vial, thereby producing adrug solution in the vial and subsequently transferring the drugsolution from the vial to the receptacle.

Preferably, the connecting the drug containing vial includes connectingthe drug containing vial to a vial head adaptor prior to the connectingthe drug containing vial. Additionally or alternatively, the receptacleport adaptor includes at least one of a spike port adaptor and a needleport adaptor.

There is yet further provided in accordance with another preferredembodiment of the present invention a vial adaptor adapted forconnection to a vial containing a drug and adapted for connection toother elements of a drug mixing system, the vial adaptor including aspike adapted for penetrating the vial, a mechanical lock for lockingthe vial adaptor to the vial once the spike penetrates the vial and anelement operative to vent the interior of the vial to the atmospherewithout permitting potentially harmful contents of the vial to reach theatmosphere.

Preferably, the vial adaptor also includes a membrane vent operative tovent the vial adaptor to the atmosphere. Additionally, the membrane ventincludes a filter. Alternatively or additionally, the membrane ventincludes a hydrophobic membrane.

Preferably, the vial adaptor also includes a septum equipped syringeport. Additionally or alternatively, the vial adaptor includes at leastone locking element, operative to irreversibly lock the vial adaptor tothe vial. Preferably, the at least one locking element includes at leastone radially extending portion and at least one transversely extendingportion.

There is further provided in accordance with yet another preferredembodiment of the present invention a vial adaptor adapted forconnection to a vial containing a drug and being adapted for connectionto other elements of a drug mixing system, the vial adaptor including atleast one locking element, operative to irreversibly lock the vialadaptor to the vial.

Preferably, the at least one locking element includes at least oneradially extending portion and at least one transversely extendingportion.

There is still further provided in accordance with another preferredembodiment of the present invention a vial adaptor adapted forconnection to a vial containing a drug and being adapted for connectionto a fluid transfer device, the vial adaptor being vented to theatmosphere in a manner which prevents release to the atmosphere ofpossibly harmful contents of the vial in a liquid, solid or gaseousform.

Preferably, the vial adaptor also includes a membrane vent operative tovent the vial adaptor to the atmosphere. Additionally, the membrane ventincludes a filter. Alternatively or additionally, the membrane ventincludes a hydrophobic membrane.

There is yet further provided in accordance with still another preferredembodiment of the present invention a syringe adaptor adapted forconnection to a syringe and adapted for connection to at least one otherelement of a drug mixing system, the syringe adaptor including a septahousing, at least two septa enclosed in the septa housing defining aspace therebetween and a needle, including a tip located in the spacewhen the syringe adaptor is not connected to the at least one otherelement.

Preferably, the septa housing is movable relative to the needle, therebyto expose the tip. Additionally or alternatively, at least a portion ofthe needle is protected by a needle protector. Additionally, the needleprotector includes an elastomeric tubing element.

There is still further provided in accordance with yet a furtherpreferred embodiment of the present invention a vial head adaptor foruse in connecting a vial with a first head circumference to a vialadaptor adapted for use with a vial with a second head circumference,the second head circumference being greater than the first headcircumference, the vial head adaptor including at least one lockingelement.

Preferably, the at least one locking element includes four lockingelements arranged generally at right angles to each other. Additionally,the at least one locking element includes a locking tooth.

There is even further provided in accordance with still anotherpreferred embodiment of the present invention a receptacle port adaptorfor use in a drug mixing system including a housing, a needle locatedwithin the housing and adapted to be inserted into a port of a fluidreceptacle, a septum located in the housing and a locking mechanism tofix the receptacle port adaptor to the port.

Preferably, the needle is protected by a needle protector. Additionally,the needle protector includes a latex needle cover. Alternatively oradditionally, the needle moves between a protected position and apiercing position.

There is also provided in accordance with yet another preferredembodiment of the present invention a protective vial housing for usewith a drug mixing system including a fluid flow passageway adapted toconnect a vial containing a drug to the drug mixing system, theprotective vial housing being operative to prevent release to theatmosphere of possibly harmful contents of the vial in a liquid, solidor gaseous form in the event of breakage of the vial.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1K, 1L and 1M aresimplified pictorial illustrations of various stages of assembly andtypical use of a drug mixing system constructed and operative inaccordance with a preferred embodiment of the present invention;

FIG. 2 is a simplified pictorial illustration of a vial head adaptorelement which forms part of the drug mixing system of FIGS. 1A-1M;

FIG. 3 is a sectional illustration taken along section lines III-III inFIG. 2;

FIG. 4 is a simplified exploded view illustration of a vial adaptorassembly which forms part of the drug mixing system of FIGS. 1A-1M;

FIG. 5 is a simplified assembled pictorial illustration of the vialadaptor assembly of FIG. 4;

FIGS. 6A and 6B are sectional illustrations taken along respectivesection lines VIA-VIA and VIB-VIB in FIG. 5;

FIG. 7 is a simplified exploded view illustration of a syringe adaptorelement which forms part of the drug mixing system of FIGS. 1A-1M;

FIG. 8 is a simplified assembled pictorial illustration of the syringeadaptor element of FIG. 7;

FIGS. 9A and 9B are sectional illustrations taken along respectivesection lines IXA-IXA and IXB-IXB in FIG. 8;

FIG. 9C is a sectional illustration of an alternative embodiment of thesyringe adaptor element of FIG. 8, taken along section lines IXA-IXA inFIG. 8.

FIG. 10 is a simplified pictorial illustration of a spike port adaptorelement which forms part of the drug mixing system of FIGS. 1A-1M;

FIGS. 11A and 11B are sectional illustrations taken along section linesXI-XI in FIG. 10, of two different inner structures of the spike portadaptor element;

FIGS. 12A and 12B are simplified pictorial illustrations of a needleport adaptor element which forms part of the drug mixing system of FIGS.1A-1M;

FIGS. 13A and 13B are sectional illustrations taken along respectivesection lines XIIIA-XIIIA and XIIIB-XIIIB in FIG. 12A;

FIG. 14 is a simplified pictorial illustration of a syringe protectioncover which forms part of the drug mixing system of FIGS. 1A-1M;

FIG. 15 is a sectional illustration taken along section lines XV-XV inFIG. 14;

FIG. 16 is a simplified pictorial illustration of an injection setadaptor element which forms part of the drug mixing system of FIGS.1A-1M;

FIG. 17 is a sectional illustration taken along section lines XVII-XVIIin FIG. 16;

FIGS. 18A and 18B are, respectively, a simplified planar illustrationand a simplified sectional illustration of the drug mixing system ofFIG. 1A during attachment of the vial adaptor, the sectionalillustration being taken along lines XVIIIB-XVIIIB in FIG. 18A;

FIGS. 19A and 19B are, respectively, a top view simplified planarillustration and a simplified sectional illustration of the drug mixingsystem of FIG. 1C during attachment of the syringe adaptor, thesectional illustration being taken along lines XIXB-XIXB in FIG. 19A;

FIGS. 19C and 19D are respectively, a side view simplified planarillustration and a simplified sectional illustration of the drug mixingsystem of FIG. 1C during attachment of the syringe adaptor, thesectional illustration being taken along lines XIXD-XIXD in FIG. 19C;

FIG. 20 is a partially pictorial partially sectional illustration of thedrug mixing system of FIG. 1D during attachment of the spike portadaptor element;

FIG. 21 is a partially pictorial partially sectional illustration of thedrug mixing system of FIG. 1D during attachment of the needle portadaptor element;

FIG. 22 is a partially pictorial partially sectional illustration of thedrug mixing system of FIGS. 1E and 20 prior to syringe attachment;

FIG. 23 is a partially pictorial partially sectional illustration of thedrug mixing system of FIGS. 1E and 20 following syringe attachment;

FIG. 24 is a partially pictorial partially sectional illustration of thedrug mixing system of FIGS. 1E and 21 prior to syringe attachment;

FIG. 25 is a partially pictorial partially sectional illustration of thedrug mixing system of FIGS. 1E and 21 following syringe attachment;

FIG. 26 is a sectional illustration of the drug mixing system of FIG. 1Gprior to drug dilution;

FIG. 27 is a sectional illustration of the drug mixing system of FIG. 1Hfollowing drug dilution;

FIG. 28 is a sectional illustration of the drug mixing system of FIGS.1K and 1L in a protected, ready for delivery state;

FIG. 29 is a partially pictorial partially sectional illustration of thedrug mixing system of FIGS. 1M and 28 when ready for injection;

FIG. 30 is a partially pictorial partially sectional illustration of thedrug mixing system of FIGS. 1M and 20 when ready for injection;

FIGS. 31A, 31B, 31C, 31D, 31E, 31F, 31G, 31H, 31I, 31J, 31K and 31L aresimplified pictorial illustrations of various stages of assembly andtypical use of a drug mixing system constructed and operative inaccordance with another preferred embodiment of the present invention;

FIG. 32 is a simplified pictorial illustration of a vial head adaptorelement which forms part of the drug mixing system of FIGS. 31A-31L;

FIG. 33 is a sectional illustration taken along section linesXXXIII-XXXIII in FIG. 32;

FIG. 34 is a simplified pictorial illustration of a spike port adaptorelement which forms part of the drug mixing system of FIGS. 31A-31L;

FIG. 35 is a sectional illustration taken along section lines XXXV-XXXVin FIG. 34;

FIG. 36 is a simplified exploded view illustration of an adaptorassembly which forms part of the drug mixing system of FIGS. 31A-31L;

FIG. 37 is a simplified pictorial illustration of a stopcock elementwhich forms part of the adaptor assembly of FIG. 36;

FIGS. 38A and 38B are sectional illustrations taken along respectivesection lines XXXVIIIA-XXXVIIIA and XXXVIIIB-XXXVIIIB in FIG. 37;

FIG. 39 is a simplified pictorial illustration of a receptacle adaptorsubassembly which forms part of the adaptor assembly of FIG. 36;

FIGS. 40A and 40B are sectional illustrations taken along respectivesection lines XLA-XLA and XLB-XLB in FIG. 39;

FIG. 41 is a simplified pictorial illustration of a vial adaptorsubassembly which forms part of the adaptor assembly of FIG. 36;

FIGS. 42A and 42B are sectional illustrations taken along respectivesection lines XLIIA-XLIIA and XLIIB-XLIIB in FIG. 41;

FIGS. 43A and 43B are simplified pictorial illustrations of a housingelement which forms part of the adaptor assembly of FIG. 36 in closedand open orientations, respectively;

FIG. 44 is a simplified assembled pictorial illustration of the adaptorassembly of FIG. 36;

FIGS. 45A and 45B are sectional illustrations taken along respectivesection lines XVA-XVA and XVB-XVB in FIG. 44;

FIG. 46 is a sectional illustration of the drug mixing system of FIG.31C during attachment of a syringe to the adaptor assembly of FIGS.44-45B;

FIG. 47 is a sectional illustration of the drug mixing system of FIG.31D during attachment of the receptacle adaptor element of FIG. 31B tothe adaptor assembly of FIG. 46;

FIG. 48 is a sectional illustration of the drug mixing system of FIG.31E during attachment of a vial to the adaptor assembly of FIG. 47;

FIG. 49 is a sectional illustration of the drug mixing system of FIGS.31F and 48 during fluid drawing from a receptacle;

FIG. 50 is a sectional illustration of the drug mixing system of FIGS.31G and 48 during fluid injection into a vial;

FIG. 51 is a sectional illustration of the drug mixing system of FIGS.31I and 48 during fluid drawing from a vial;

FIG. 52 is a sectional illustration of the drug mixing system of FIGS.31J and 48 during fluid injection into a receptacle;

FIG. 53 is a sectional illustration of the drug mixing system of FIG.31L when ready for storage;

FIGS. 54A, 54B, 54C, 54D, 54E, 54F, 54G and 54H are simplified pictorialillustrations of various stages of assembly and typical use of a drugmixing system constructed and operative in accordance with yet anotherpreferred embodiment of the present invention;

FIG. 55 is a simplified pictorial illustration of a vial head adaptorelement which forms part of the drug mixing system of FIGS. 54A-54H;

FIG. 56 is a sectional illustration taken along section lines LVI-LVI inFIG. 55;

FIG. 57 is a simplified pictorial illustration of a spike port adaptorelement which forms part of the drug mixing system of FIGS. 54A-54H;

FIG. 58 is a sectional illustration taken along section linesLVIII-LVIII in FIG. 57;

FIG. 59 is a simplified exploded view illustration of an adaptorassembly which forms part of the drug mixing system of FIGS. 54A-54H;

FIG. 60 is a simplified pictorial illustration of ad vial adaptorsubassembly which forms part of the adaptor assembly of FIG. 59;

FIGS. 61A and 61B are sectional illustrations taken along respectivesection lines LXIA-LXIA and LXIB-LXIB in FIG. 60;

FIG. 62 is a simplified pictorial illustration of a receptacle adaptorsubassembly which forms part of the adaptor assembly of FIG. 59;

FIGS. 63A and 63B are sectional illustrations taken along respectivesection lines LXIIIA-LXIIIA and LXIIIB-LXIIIB in FIG. 62;

FIGS. 64A and 64B are simplified pictorial illustrations of a housingelement which forms part of the adaptor assembly of FIG. 59 in closedand open orientations, respectively;

FIG. 65 is a simplified assembled pictorial illustration of the adaptorassembly of FIG. 59;

FIGS. 66A and 66B are sectional illustrations taken along respectivesection lines LXVIA-LXVIA and LXVIB-LXVIB in FIG. 65;

FIGS. 67A and 67B are sectional illustrations of the drug mixing systemof FIG. 54C during attachment of a vial to the adaptor assembly of FIG.65;

FIG. 68 is a sectional illustration of the drug mixing system of FIG.54D-54G during attachment of the receptacle port adaptor element of FIG.54B to the adaptor assembly of FIG. 67;

FIG. 69 is a sectional illustration of the drug mixing system of FIGS.54H and 68 during disconnection of the receptacle port adaptor elementof FIG. 54B from the adaptor assembly of FIG. 67;

FIG. 70 is an exploded view illustration of a drug mixing system whichis constructed and operative in accordance with a further preferredembodiment of the present invention;

FIG. 71 is a simplified pictorial illustration of a vial support elementwhich forms part of the drug mixing system of FIG. 70;

FIGS. 72A and 72B are, respectively, a sectional illustration and apictorial sectional illustration taken along section lines LXXII-LXXIIin FIG. 71;

FIG. 73 is a simplified pictorial illustration of the vial supportelement of FIG. 71, when containing a vial;

FIG. 74 is a sectional illustration taken along section linesLXXIV-LXXIV in FIG. 73;

FIGS. 75A and 75B are simplified pictorial illustrations of a vialpuncturing cover element which forms part of the vial adaptorsubassembly of FIG. 70;

FIG. 76 is a sectional illustration taken along section linesLXXVI-LXXVI in FIG. 75A;

FIG. 77 is a simplified assembled pictorial illustration of the vialadaptor subassembly of FIG. 70;

FIG. 78 is a sectional illustration taken along section linesLXXVIII-LXXVIII in FIG. 77;

FIG. 79 is a pictorial illustration of the vial adaptor assembly of FIG.77 when assembled to an adaptor assembly in accordance with a preferredembodiment of the present invention;

FIG. 80 is a sectional illustration taken along section lines LXXX-LXXXin FIG. 79;

FIG. 81 is a pictorial illustration taken of the vial adaptor assemblyand adaptor assembly of FIG. 79 when connected to a receptacle portadaptor element and a receptacle in accordance with a preferredembodiment of the present invention;

FIG. 82 is a sectional illustration taken along section linesLXXXII-LXXXII in FIG. 81;

FIG. 83 is an exploded view illustration of a drug mixing system whichis constructed and operative in accordance with a still furtherpreferred embodiment of the present invention;

FIG. 84 is a simplified pictorial illustration of a receptacle adaptorhousing assembly which forms part of the drug mixing system of FIG. 83;

FIGS. 85A and 85B are sectional illustrations taken along section linesLXXXVA-LXXXVA and LXXXVB-LXXXVB in FIG. 84;

FIG. 86 is a simplified pictorial illustration of a receptacle adaptorneedle element which forms part of the drug mixing system of FIG. 83;

FIGS. 87A and 87B are sectional illustrations taken along section linesLXXXVIIA-LXXXVIIA and LXXXVIIB-LXXXVIIB in FIG. 86;

FIG. 88 is a simplified assembled pictorial illustration of thereceptacle adaptor subassembly of FIG. 83;

FIGS. 89A and 89B are sectional illustrations taken along section linesLXXXIXA-LXXXIXA and LXXXIXB-LXXXIXB in FIG. 88;

FIG. 90 is a pictorial illustration of the receptacle adaptorsubassembly of FIG. 88 when assembled to a vial adaptor subassembly inaccordance with a preferred embodiment of the present invention, priorto connection of a needle to a receptacle port element;

FIG. 91 is a sectional illustration taken along section lines XCI-XCI inFIG. 90;

FIG. 92 is a pictorial illustration of the receptacle adaptorsubassembly of FIG. 88 when assembled to a vial adaptor subassembly,following connection of a needle to a receptacle port element; and

FIG. 93 is a sectional illustration taken along section linesXCIII-XCIII in FIG. 92.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is now made to FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J,1K, 1L and 1M which are simplified pictorial illustrations of variousstages of assembly and typical use of a drug mixing system constructedand operative in accordance with a preferred embodiment of the presentinvention.

As seen in FIG. 1A, a conventional vial 10, including a top portion 12and a neck portion 13, is pushed into engagement with a vial adaptorassembly 30 which is described hereinbelow with reference to FIGS. 4-6B.Top portion 12 of vial 10 preferably has a septum 31 sealingly seatedtherein. FIGS. 18A-18B show a sectional view of the drug mixing systemat this stage.

Alternatively, if a small vial 32 is used, small vial 32 is pushed intoengagement with a vial head adaptor element 34 which is describedhereinbelow with reference to FIGS. 2-3 as shown in FIG. 1B, and is thenpushed into engagement with vial adaptor assembly 30. The vials 10 and32 typically contain a drug in a soluble powder form, in a solution orin other suitable form.

As shown in FIG. 1C, a luer fitted hypodermic syringe 40 having aplunger 42 and a luer tip 44 is attached to a syringe adaptor element 50which is described hereinbelow with reference to FIGS. 7-9B. FIGS.19A-19D show planar and sectional views of the drug mixing system atthis stage.

FIG. 1D shows a spike port adaptor element 60, as described hereinbelowwith reference to FIGS. 10-11, being inserted into a spike port 61 in areceptacle 62 containing a fluid. FIG. 20 shows a partially pictorialpartially sectional view of the drug mixing system at this stage.Typically, receptacle 62 comprises a bag, and the fluid containedtherein is sterile saline solution, water, or any other suitable sterilesolution or pure fluid.

Alternatively, a needle port adaptor element 70, as describedhereinbelow with reference to FIGS. 12A-13B, is inserted into a needleport 64 in receptacle 62. FIG. 21 shows a sectional view of the drugmixing system at this stage.

It will be appreciated by persons skilled in the art that the assemblysteps shown in FIGS. 1B-1D may be performed in any suitable sequence.

As seen in FIG. 1E, syringe adaptor element 50, having syringe 40attached thereto (FIG. 1C), is connected to a connection port in eitherof spike port adaptor element 60 or needle port adaptor element 70 ofFIG. 1D. FIGS. 22-23 and 24-25, respectively, show partially pictorialpartially sectional views of the two alternate orientations of the drugmixing system at this stage.

Typically, plunger 42 of syringe 40 is fully pushed inward into syringe40 before syringe adaptor element 50 is connected to either of spikeport adaptor element 60 and needle port adaptor element 70.

As seen in FIG. 1F, a user retracts plunger 42 in either of theoperative orientations of FIG. 1E, thus at least partially fillingsyringe 40 with fluid drawn from receptacle 62. The fluid flows throughthe spike port adaptor element 60 or through the needle port adaptorelement 70 directly into syringe 40. This flow of fluid ensures that thefluid remains sterile, and that the user is not exposed to the fluid.Subsequently, the syringe 40 and syringe adaptor element 50 aredisconnected from the spike port adaptor element 60 or the needle portadaptor element 70. The drug mixing system of the present invention alsoensures that the user is not exposed to the fluid during disconnectionthereof, as explained further hereinbelow.

The user then connects syringe adaptor element 50, which is attached tosyringe 40, to the vial adaptor assembly 30 having the vial 10 attachedthereto, as shown in FIG. 1G. FIG. 26 shows a sectional view of the drugmixing system at this stage.

When the syringe 40 and vial 10 are connected and fluid can flowtherebetween, the user pushes plunger 42 inward, with the vialpositioned upright, thus injecting the fluid contained in syringe 40into vial 10 and dissolving the drug contained therein. FIG. 27 shows asectional view of the drug mixing system at this stage.

As seen in FIG. 1H, the user then shakes the drug mixing system of FIG.1G to ensure that the drug in vial 10 is fully dissolved and that theresulting solution is homogenous.

It is appreciated that when vial 10 contains a drug in a pre-dissolvedform, the steps described hereinabove with reference to FIGS. 1E-1H maybe obviated.

As seen in FIG. 1I, the user turns the drug mixing system upside downand retracts plunger 42, thus drawing at least part of the solution fromthe vial 10 into syringe 40. Subsequently, syringe 40 and syringeadaptor element 50 are disconnected from vial 10 and vial adaptorassembly 30, as shown in FIG. 1J. At this stage, if some of the drugsolution is left in vial 10, vial 10 and vial adaptor assembly 30,joined thereto, may be stored in a suitable facility for further use.

At a next stage, the drug solution contained in syringe 40 is preparedfor delivery to a hospital ward for infusion into a patient. As shown inFIG. 1K, syringe 40 containing the drug solution is connected to spikeport adaptor element 60 for transferring the drug into receptacle 62.Alternatively, syringe 40 may be connected to needle port adaptorelement 70.

As a further alternative, the user may place a syringe protection cover80, which is described hereinbelow with reference to FIGS. 14-15, ontothe syringe adaptor element 50 which is attached to syringe 40, prior todelivering it to a hospital ward.

As seen in FIG. 1L, the user pushes plunger 42 of syringe 40 inward,thus injecting the drug solution into receptacle 62 and further dilutingit prior to infusion into a patient. Alternatively, syringe 40 may becovered by the syringe protection cover 80 and is ready for delivery tothe appropriate hospital ward. FIG. 28 is a sectional view of the drugmixing system at this stage.

As seen in FIG. 1M, the receptacle 62 and spike port adaptor element 60are connected via a standard infusion set 92 such as model IAS which iscommercially available from Teva Medical Ltd. of Ashdod, Israel, to apatient's intravenous cannula. The connection to the spike port adaptorelement 60 is performed after the removal of a connection element whichis placed at the end of the spike port adaptor element 60. FIG. 30 is asectional view of the drug mixing system at this stage.

Alternatively, the syringe 40 and syringe adaptor element 50 may beconnected via an infusion set adaptor element 90, which is describedhereinbelow with reference to FIGS. 16-17, to an infusion set 92including a port 93 and an intravenous cannula 94 which is placed at theinjection site. Before syringe adaptor element 50 is attached to theinfusion set adaptor element 90, the syringe protection cover 80 isremoved from the end of the syringe adaptor element 50. FIG. 29 shows apartially pictorial partially sectional view of the drug mixing systemat this stage.

The structure of elements of the drug mixing system of FIGS. 1A-1M isdescribed hereinbelow with reference to FIGS. 2-17.

Reference is now made to FIG. 2, which is a simplified pictorialillustration of a vial head adaptor element 34 which forms part of thedrug mixing system of FIGS. 1A-1M, and to FIG. 3, which is a sectionalillustration taken along section lines III-III in FIG. 2.

As seen in FIG. 2, vial head adaptor element 34 is preferably aside-to-side symmetric integrally formed element, which is preferablyinjection molded of plastic.

Vial head adaptor element 20 preferably includes a generally cylindricalmain body portion 200 and has a central axis 201. An inner cylindricalsurface 202 of main body portion 200 preferably has four arms 204extending therefrom, each arm 204 being arranged at generally rightangles with respect to its neighboring arms.

Each of arms 204 terminates at an upper end thereof, in the sense ofFIG. 1B, in an inwardly facing generally triangular tooth 206 having aforwardly facing inclined surface 208 and a bottom-facing engagementsurface 210 extending generally perpendicular to arm 204.

At bottom surface of vial head adaptor element 34, there are formed fourinwardly protruding surfaces 212, extending generally perpendicular toinner surface 202 of main body portion 200. Each of neighboring surfaces212 is preferably arranged at a generally right angle with respect toits neighboring surfaces 212. Surfaces 212 and arms 204 are rotationallyoffset from one another about axis 201.

Reference is now made to FIG. 4, which is a simplified exploded viewillustration of a preferred vial adaptor assembly 30 which forms part ofthe drug mixing system of FIGS. 1A-1M, to FIG. 5, which is a simplifiedassembled pictorial illustration of the vial adaptor assembly 30, and toFIGS. 6A and 6B, which are sectional illustrations taken alongrespective section lines VIA-VIA and VIB-VIB in FIG. 5.

As seen in FIGS. 4-6B, vial adaptor assembly 30 comprises a main bodyelement 302 arranged generally about an axis 303. Main body element 302is preferably integrally formed and preferably injection molded ofplastic.

Main body element 302 is preferably side-to-side symmetric about axis303, and preferably includes a rear portion 304, which is generallycylindrical and terminates in a forward wall 306. Rear portion 304comprises a forward base section 308, rearward of which are preferablyformed four tabs 310 each having a rectangular window 312. Rearward ofrectangular windows 312 and on an inner surface 314 of each of tabs 310there are preferably formed two radially extending inwardly facingprotrusions 316 each having an inclined surface. Protrusions 316preferably terminate at a forward end thereof in an inwardly facingtransversely extending protrusion 318. Rearward of protrusions 316, eachof tabs 310 preferably includes an outwardly tapered portion 320.

A hollow vial puncturing spike 322 extends rearwardly from a rearwardsurface 324 of forward wall 306, and is surrounded by base section 308and by tabs 310. Rearward surface 324 additionally includes a circularcylindrical protrusion 325, surrounding puncturing spike 322. Tworadially extending bores 326 and 327 extend through vial puncturingspike 322.

Forward of forward wall 306 of rear portion 304 there is formed anintermediate portion 328 which is generally rectangular, and includesaxial hollow tubular portion 330 which is in fluid flow engagement withbore 327 of vial puncturing spike 322.

At a top surface of intermediate portion 328 and slightly recessed withrespect thereto there is formed a plastic membrane support surface 332,having formed thereon a plurality of generally evenly distributedspherical protrusions 334, which are adapted to support a hydrophobicmembrane 336 and prevent it from excessive inflation and from cracking.Membrane 336 is adapted to allow free passage of air into the main bodyelement 302, but to prevent passage therethrough of liquid and air-borneparticles, microorganisms and aerosol. A preferred membrane 336 is ModelVersapor R 0.2 Micron which is commercially available from PallCorporation of New York, U.S.A. Membrane 336 is in fluid flow engagementwith vial puncturing spike 322 via bore 326 and via a recess 337 formedin intermediate portion 328.

A rim 338 surrounding support surface 332 is adapted to support anoptional carbon cloth filter 340 and maintain it in a raised positionabove and spaced from membrane 336. Carbon cloth filter 340 is adaptedto prevent toxic vapors from escaping from main body element 302, thusprotecting users. A preferred carbon cloth filter 340 is Model No.Zorflex EMI, which is commercially available from Charcoal ClothInternational Ltd. of Houghton-le-Spring, England.

Intermediate portion 328 terminates at a forward end thereof in agenerally circular wall 342. Forward of circular wall 342 there isformed a hollow neck portion 344, which is in fluid flow engagement withhollow tubular portion 330 and with hollow vial puncturing spike 322.Hollow neck portion 344 terminates at a forward end thereof in agenerally circular wall surface 346.

Forward of neck portion 344 there is formed a forward facing portion348, which is adapted to sealingly accommodate a generally circularseptum 350 on a seat 352 which is located at a forward end of portion348. Forward facing portion 348 defines a central bore 354 whichcommunicates between tubular portion 330 and septum 350.

Vial adaptor assembly 30 preferably additionally includes a coveringelement 360 which supports and covers membrane 336 and carbon filter340. Covering element 360 is a generally cylindrical, generallyside-to-side symmetric, element and is preferably formed with a centralopening 362 at a forward end thereof through which forward portion 348extends.

A pair of outer side surfaces 364 of covering element 360 are eachformed with ribbed grip regions 366. An inner top surface 368 ofcovering element 360 is preferably flat, and is adapted to support thetop surfaces of membrane 336 and carbon filter 340 and to preventexcessive inflation and cracking thereof.

It is appreciated that the functionalities of membrane 336 and carboncloth filter 340, to allow free passage of air into the drug mixingsystem while preventing passage thereinto of liquid and air-borneparticles, microorganisms and aerosol and preventing toxic vapors fromescaping from the drug mixing system, may be incorporated, using similarelements, into any of syringe adaptor element 50, spike port adaptorelement 60 and needle port adaptor element 70.

Reference is now made to FIG. 7, which is a simplified exploded viewillustration of syringe adaptor element 50 which forms part of the drugmixing system of FIGS. 1A-1M, to FIG. 8, which is a simplified assembledpictorial illustration of syringe adaptor element 50 and to FIGS. 9A, 9Band 9C, which are sectional illustrations taken along respective sectionlines IXA-IXA and IXB-IXB in FIG. 8.

As seen with particular clarity in FIG. 7, syringe adaptor element 50comprises a housing element 500, which has seated therein a forwardseptum 502 and a rearward septum 504.

Housing element 500 is preferably an integrally formed cylindricalhollow element made of plastic and is preferably side-to-side,top-to-bottom and forward-rearward symmetrical.

Preferably, a forward portion 506 of housing element 500 includes a seat508 for forward septum 502, and a rear portion 510 of the housingelement includes a seat 512 for rearward septum 504. An intermediateportion 514 of housing element 500 preferably includes on a top and abottom surface thereof generally rectangular outwardly facingprotrusions 516.

Septa 502 and 504 are preferably formed to have a generally circularportion 518 with a partially spherical protrusion 520 at one sidethereof.

Surrounding housing element 500 there is formed a body 522, whichdefines a main body portion 523, which is generally cylindrical,preferably side-to-side and top-to-bottom symmetrical, and preferablyformed of plastic, and side surfaces 524. Extending from a forwardportion of each of side surfaces 524 is an outwardly protruding arm 526,defining at an inner facing forward end thereof a generally triangulartooth 527 having a transversely extending rearward facing surface 528which is adapted to engage a forward facing surface of intermediateportion 514 of housing element 500.

Rearward of each of arms 526 there is formed a generally rectangularaperture 529. Adjacent a rearward portion 530 of housing element 500there is formed a circumferential protrusion 532, forward of which isformed an additional circumferential protrusion 534, having a slightlylarger outer circumference than that of protrusion 532.

A compression spring 536 is seated within housing element 500, on ashoulder 538 located between intermediate portion 514 and rear portion510 of housing element 500.

A generally cylindrical rear sealing element 540 is located rearward ofhousing element 500. Rear sealing element 540 is preferably side to sidesymmetric, and is typically formed of plastic.

Rear sealing element 540 preferably defines a forward cowl 542terminating at a rearward end thereof in a generally circular wallportion 544. Forward cowl 542 preferably includes a circumferentialrecess 546, which is adapted to engage circumferential protrusion 532 ofhousing element 500. A forward facing surface 547 of sealing element 540is adapted to engage a rearward facing surface of additionalcircumferential protrusion 534 when the syringe adaptor element 500 isassembled. Wall portion 544 preferably defines a rear spring seat forcompression spring 536.

A tapered inner portion 548 of rear sealing element 540, which has asmaller circumference than that of housing element 500, is preferablytherewithin at a rear portion thereof. Inner portion 548 is formedforward of and immediately adjacent to wall portion 544 and lies withincompression spring 536. A radially extending bore 549 is preferablyformed in inner portion 548 and a hollow needle 550 is sealingly mountedtherein. Inner portion 548 is preferably surrounded by a cylindricalportion 552, which terminates at a rearward end thereof in wall portion544 and which also has a circumference which is smaller than that ofhousing element 500.

Needle 550 preferably extends axially within compression spring 536 andthrough the center of housing element 500 and rearward septum 504. Asharpened tip of needle 550 is preferably placed between forward septum502 and rearward septum 504, thus maintaining the needle inaccessible toa user and to the atmosphere.

Two generally concave symmetric surfaces 554 forming a nearly completecylinder, may extend rearwardly of wall portion 544 and preferablysurround an inner rearward cylindrical portion 556, which is adapted toengage the luer tip 44 of luer fitted syringe 40, defining generallysymmetric side-facing tabs 558 at rearward ends thereof. The rearportion of needle 550 preferably extends axially within innercylindrical portion 556.

Referring specifically to FIG. 9C, which illustrates an alternativeembodiment of the syringe adaptor element of FIG. 8, it is seen that aneedle protector 560, preferably made of latex, at least partiallycovers needle 550, thus protecting it from the surrounding atmosphere.

Reference is now made to FIG. 10, which is a simplified pictorialillustration of spike port adaptor element 60 which forms part of thedrug mixing system of FIGS. 1A-1M and to FIGS. 11A and 11B which aresectional illustrations taken along section lines XI-XI in FIG. 10.

Spike port adaptor element 60 preferably comprises a hollow flexibleplastic tube 602 having associated therewith a standard clamp 604, whichis commercially available from various manufacturers, such as Qosina ofItaly.

At a forward end thereof, tube 602 is fitted with a hollow spike element606 which is preferably side-to-side symmetric and formed of plastic.Spike element 606 is preferably formed of a main body portion 607 whichpreferably defines at a forward end thereof a spike 608, having formedtherein apertures communicating with two axially extending bores 610 and612. Rearward of spike 608, main body portion 607 defines a generallysemi-circular planar protrusion 614 adapted to define the location atwhich a user grips the spike.

Alternatively, as seen with particular clarity in FIG. 11B, main bodyportion 607 may have formed therein a single aperture, whichcommunicates with a single axially extending bore 615.

The interior of tube 602 is in fluid flow communication with bore 612. Abore 616 formed in a neck portion 618 which preferably extendstransversely from main body portion 607 and communicates with bore 610.Hollow neck portion 618 preferably terminates in a forward facingcylindrical portion 620, which sealingly accommodates a generallycircular septum 622 located on a seat 624 which communicates with bore616.

A sealing assembly 630 is preferably attached to a rear end of tube 602.Sealing assembly 630 preferably includes at a rearwardmost end thereof aselectably removable tapered sealing section 632, forward of which thereis formed a connecting tube portion 634 which is adapted to connectsealing section 632 to tube 602. Sealing assembly 630 is adapted to sealtube 602 during use of the drug mixing device, and may be removed fromtube 602 when receptacle 62 is connected directly to an infusion setspike for infusion of the fluid contained therein to a patient.

It is appreciated that the spike connector of connection assembly 630 ofspike port adaptor element 60 may optionally be replaced by a luerconnector.

Reference is now made to FIGS. 12A and 12B, which are simplifiedpictorial illustrations of needle port adaptor element 70 which formspart of the drug mixing system of FIGS. 1A-1M and to FIGS. 13A and 13B,which are sectional illustrations taken along respective section linesXIIIA-XIIIA and XIIIB-XIIIB in FIG. 12A.

Needle port adaptor element 70 preferably comprises a main body element700 arranged generally about an axis 701. Main body element 700 ispreferably integrally formed and preferably injection molded of plastic.

Main body element 700 is preferably side-to-side symmetric about axis701, and preferably includes a rear portion 702 which is generallycylindrical, terminating in a forward wall portion 704 having a bore 706extending therethrough. Each of side surfaces 708 of rear portion 702preferably includes a ribbed engagement surface portion 710.

Four axially extending slots 712 extend along rear portion 702, eachslot 712 being arranged at generally right angles with respect to itsneighboring slots. Defined between slots 712 at a rearward facing end ofrear portion 702 are four outwardly tapering tabs 714. Each tab 714includes an inwardly facing generally triangular tooth 715 andterminates in a transversely extending section 716. Rear portion 702preferably surrounds a generally cylindrical portion 718, which extendsrearwardly from forward wall portion 704.

Forward of wall portion 704 there is formed a neck portion 720, defininga radially extending bore 722. A hollow needle 724 is adhesively mountedin bore 722 and extends rearwardly thereof along axis 701.

Forward of neck portion 720 there is formed a forward facing cylindricalportion 726, which sealingly supports a generally circular septum 728 ona seat 730 which is located at a forward end of cylindrical portion 726.A bore 732 preferably extends radially through forward facingcylindrical portion 726. Bore 732 is preferably in fluid flow engagementwith the interior of hollow needle 724.

A generally conical cover element 740 which is generally side-to-sideand top-to-bottom symmetric about axis 701 preferably is axiallyslidable with respect to main body element 700 for selectablysurrounding rear portion 702 of main body element 700.

A rear portion 742 of cover element 740 is preferably outwardly tapered,and terminates in a transversely extending edge surface 744. Fouroutwardly facing radially extending protrusions 746 lie along an outersurface of cover element 740, each protrusion 746 being arranged atgenerally right angles with respect to its neighboring protrusions.

Four outwardly facing generally circumferential protrusions 748 arepreferably formed on an outer surface 750 of cover element 740 betweenprotrusions 746 thus defining a grip region.

At a forward end thereof, an inner surface 751 of cover element 740includes an inwardly tapered section 752, which is adapted to slidablyengage ribbed engagement surface portion 710 of rear portion 702 of mainbody element 700. Four generally rectangular inwardly facing protrusions754 extend from section 752, each protrusion 754 being arranged atgenerally right angles with respect to its neighboring protrusions.Protrusions 754 are adapted to slidably engage slots 712 of rear portion702 of main body element 700.

Reference is now made to FIG. 14, which is a simplified pictorialillustration of syringe protection cover 80 which forms part of the drugmixing system of FIGS. 1A-1M and to FIG. 15, which is a sectionalillustration taken along section lines XV-XV in FIG. 14.

Syringe protection cover 80 is preferably integrally formed, and isgenerally side to side symmetric about an axis 800. A generally circularlocking element 802 is preferably formed at a bottom end of syringeprotection cover 80.

Locking element 802 preferably includes a flat generally circular basesurface 804, preferably extending along a plane which is perpendicularto axis 800. Surface 804 is integrally formed with a generallycylindrical portion 806. Cylindrical portion 806 terminates in agenerally circular radially outwardly extending wall portion 808, whichlies in a plane parallel to that defined by surface 804. Wall portion808 terminates in a generally cylindrical portion 810, which generallysurrounds cylindrical portion 806. An elongate tab 812 extends fromsurface 804 along axis 800.

Reference is now made to FIG. 16, which is a simplified pictorialillustration of infusion set adaptor element 90 which forms part of thedrug mixing system of FIGS. 1A -1M and to FIG. 17, which is a sectionalillustration taken along section lines XVII-XVII in FIG. 16.

As seen in FIGS. 16 and 17, infusion set adaptor element 90 ispreferably integrally formed, and preferably is side-to-side symmetricalong an axis 901.

Infusion set adaptor element 90 preferably includes a forward facingcylindrical portion 902, which is adapted to surround a generallycircular septum 904 which is sealingly mounted onto a seat 906 which islocated at a forward end of cylindrical portion 902.

A generally cylindrical intermediate portion 908 is formed rearward ofcylindrical portion 902, having an outer circumference which is slightlysmaller than that of cylindrical portion 902. At a rear end thereof,intermediate portion 908 tapers toward a cylindrical neck portion 910,which has an outer circumference which is smaller than that ofintermediate portion 908.

An axially extending bore 912 extends through neck portion 910,intermediate portion 908 and cylindrical portion 902, thus allowingfluid flow through infusion set adaptor element 90 when the septum 904is suitably pierced.

The assembled structure of the drug mixing system at various stages ofuse thereof is described hereinbelow with reference to FIGS. 18A-30.

Reference is now made to FIGS. 18A and 18B which are, respectively, asimplified planar illustration and a simplified sectional illustrationof the drug mixing system of FIG. 1B during attachment of vial adaptor30, the sectional illustration being taken along lines XVIIIB-XVIIIB inFIG. 18A.

As seen with particular clarity in FIG. 18B, vial puncturing spike 322of vial adaptor assembly 30 punctures septum 31 located inside topportion 12 of vial 10, thus enabling fluid flow between the main body ofvial 10 and forward facing portion 348 of main body element 302 of vialadaptor assembly 30. Preferably, puncturing of septum 31 releases anyvacuum in vial 10 by entrance of air into vial 10 through carbon filter340 (FIGS. 4 and 6B) and membrane 336 (FIGS. 4 and 6B).

Engagement between vial adaptor assembly 30 and vial 10 is preferablymaintained by snap engagement of protrusions 316 and 318 of rear portion304 of main body element 302 with a neck portion 13 of vial 10. Theengagement of protrusions 316 and 318 with neck portion 13 ensures thatvial adaptor assembly 30 is latched onto vial 10 and cannot be removedtherefrom. Tabs 310 and outwardly tapered portions 320 generallysurround top portion 12 and neck portion 13 of vial 10.

Reference is now made to FIGS. 19A and 19B and to FIGS. 19C and 19Dwhich are, respectively, a top and a side view simplified planarillustration and a simplified sectional illustration of the drug mixingsystem of FIG. 1C during attachment of the syringe adaptor element 50 tosyringe 40, the sectional illustrations being taken along linesXIXB-XIXB in FIG. 19A and XIXD-XIXD in FIG. 19C.

As seen in FIGS. 19A-19D, luer 44 of luer fitted hypodermic syringe 40preferably engages inner rearward cylindrical portion 556 of sealingelement 540 of syringe adaptor element 50 and tabs 558 formed thereon,such that needle 550 is in fluid flow engagement with the hollow body ofsyringe 40.

At this stage, the sharpened tip of needle 550 is preferably placedbetween septa 502 and 504, and compression spring 536 is relaxed.Preferably, when syringe 40 is connected to syringe adaptor assembly 50,plunger 42 of syringe 40 is pushed fully inward with respect to thesyringe.

Reference is now made to FIG. 20, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIG. 1Dduring attachment of spike port adaptor element 60.

As seen in FIG. 20, spike 608 of spike element 606 of spike port adaptorelement 60 is preferably inserted into a spike port 61 of receptacle 62.At this stage, receptacle 62 and tube 602 are in fluid flow engagement.However, clamp 604 is closed and prevents fluid from flowing out of thereceptacle through bore 612 into tube 602. Additionally, bore 610 is influid flow communication with cylindrical portion 620 via bore 616 ofneck portion 618.

Reference is now made to FIG. 21, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIG. 1Dduring attachment of needle port adaptor element 70.

As seen in FIG. 21, needle 724 of needle port adaptor element 70 ispreferably inserted into needle port 64 of receptacle 62. Preferably,teeth 715 of tabs 714 engage port 64 when needle 724 is inserted.Additionally, after needle 724 is inserted, cover element 740 ispreferably moved with respect to main body element 700 along ribbedengagement surface portion 710 (FIG. 13B).

The axial displacement of cover element 740 preferably seals and locksthe connection between main body element 700 and port 64, by pressing ontabs 714 and pushing them inward. Displacement of cover element 740includes a corresponding axial displacement of protrusions 754 withrespect to slots 712 of rear portion 702 of main body element 700. Theaxial displacement terminates when sections 716 of tabs 714 engage innersurface 751 of cover element 740.

At this stage, receptacle 62 is preferably in fluid flow engagement withbore 732 of cylindrical portion 726 via intermediate portion 720 andneedle 724. However, fluid does not flow out of cylindrical portion 726,as the cylindrical portion is sealed by septum 728.

Reference is now made to FIG. 22, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIGS. 1Eand 20 prior to the attachment of syringe 40 and syringe adaptor element50 to spike port adaptor element 60.

As seen in FIG. 22, syringe adaptor element 50 and syringe 40 joinedthereto are placed in close proximity to cylindrical portion 620 ofspike port adaptor element 60. It is appreciated that at this stagecompression spring 536 is relaxed and the sharpened tip of needle 550 ispreferably placed between septa 502 and 504. Preferably, surfaces 528 ofteeth 527 of arms 526 engage forward facing surfaces on either side ofintermediate portion 514 of housing element 500.

Throughout the engagement process, septum 622 of spike port adaptorelement 60 and septum 502 of syringe adaptor element 50 are pushed intotouching engagement by the biasing force of spring 536, thus preventingexposure of the tip of needle 550 to the environment.

Reference is now made to FIG. 23, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIGS. 1Eand 20 following the attachment of syringe 40 and syringe adaptorelement 50 to spike port adaptor element 60.

As seen in FIG. 23 syringe adaptor element 50 and syringe 40 joinedthereto are pushed into engagement with cylindrical portion 620 of spikeport adaptor element 60.

Preferably, surfaces 528 of teeth 527 of arms 526 snap into engagementwith wall portion 618, thus ensuring that the engagement between syringeadaptor element 50 and cylindrical portion 620 is secure. At this stage,spring 536 is in a compressed state, and housing element 500 is pushedrearwardly by the pressure from cylindrical portion 620.

The rearward motion of housing element 500 causes the sharpened tip ofneedle 550 to pierce septa 502 and 622. As a result, needle 550partially extends through the hollow space in cylindrical portion 620,and is in fluid flow engagement with receptacle 62 via bore 610 of spike608 of spiked element 606 and via bore 616 of neck portion 618. Due tothe fluid flow engagement between luer 44 of syringe 40 and needle 550of syringe adaptor element 50, the syringe 40 is now in fluid flowengagement with receptacle 62. It is appreciated that when using thesyringe adaptor element described in FIG. 9C, needle protector 560 atleast partially collapses, thus exposing the needle 550.

In order to draw fluid from receptacle 62 into syringe 40 via spikedelement 606, bore 616 of neck portion 618, cylindrical portion 620 andneedle 550, a user retracts plunger 42. In order to disengage syringeadaptor element 50 and cylindrical portion 620, a user pushes slightlyon arms 526 extending from side surfaces 524 of housing element 522,causing teeth 527 to move outward and release a rearward facing surfaceof cylindrical portion 620, thus disconnecting the cylindrical portion.

Throughout the disengagement process, septum 622 of spike port adaptorelement 60 and septum 502 of syringe adaptor element 50 are pushed intotouching engagement by the biasing force of spring 536, thus preventingexposure of the tip of needle 550 to the environment.

Reference is now made to FIG. 24, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIGS. 1Eand 21 prior to the attachment of syringe 40 and syringe adaptor element50 to needle port adaptor element 70. As seen in FIG. 24, syringeadaptor element 50 and syringe 40 joined thereto are placed in closeproximity to cylindrical portion 726 of needle port adaptor element 70.It is appreciated that at this stage compression spring 536 is relaxedand the sharpened tip of needle 550 is preferably located between septa502 and 504. Preferably, surfaces 528 of teeth 527 of arms 526 engageforward facing surfaces on either side of intermediate portion 514 ofhousing element 500.

Reference is now made to FIG. 25, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIGS. 1Eand 21 following the attachment of syringe 40 and syringe adaptorelement 50 to needle port adaptor element 70. As seen in FIG. 25 syringeadaptor element 50 and syringe 40 joined thereto are pushed intoengagement with cylindrical portion 726 of needle port adaptor element70.

Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage arearward facing wall portion of cylindrical portion 726, thus ensuringthat the engagement between syringe adaptor element 50 and cylindricalportion 726 is secure. At this stage, spring 536 is in a compressedstate, and housing element 500 is pushed rearwardly by the pressure fromcylindrical portion 726.

The rearward motion of housing element 500 causes the sharpened tip ofneedle 550 to pierce septa 502 and 728. As a result, needle 550partially extends through bore 732 of cylindrical portion 726, and is influid flow engagement with receptacle 62 via needle 724 of rear portion702, neck portion 720 of main body element 700 and bore 732 ofcylindrical portion 726. Due to the fluid flow engagement between luer44 of syringe 40 and needle 550 of syringe adaptor element 50, thesyringe 40 is now in fluid flow engagement with receptacle 62. It isappreciated that when using the syringe adaptor element described inFIG. 9C, needle protector 560 at least partially collapses, thusexposing the needle 550.

In order to draw fluid from receptacle 62 into syringe 40 via needle724, bore 732 and needle 550, a user retracts plunger 42. In order todisengage syringe adaptor element 50 and cylindrical portion 726, a userpushes slightly on arms 526 extending from side surfaces 524 of housingelement 522, causing teeth 527 to move outward and release a rearwardfacing wall portion of cylindrical portion 726, thus disconnectingcylindrical portion 726.

Throughout the engagement and disengagement process, septum 728 ofneedle port adaptor element 70 and septum 502 of syringe adaptor element50 are pushed into touching engagement by the biasing force of spring536, thus preventing exposure of the tip of needle 550 to theenvironment.

Reference is now made to FIG. 26, which is a sectional illustration ofthe drug mixing system of FIG. 1G prior to drug dilution.

As seen in FIG. 26, syringe adaptor element 50 and syringe 40 joinedthereto are placed in close proximity to forward facing portion 348 ofvial adaptor element 30. It is appreciated that at this stagecompression spring 536 is relaxed and the sharpened tip of needle 550 ispreferably located between septa 502 and 504. Preferably, surfaces 528of teeth 527 of arms 526 engage forward facing surfaces on either sideof intermediate portion 514 of housing element 500.

At this stage, syringe 40 is preferably filled with a fluid drawn fromreceptacle 62 (FIGS. 22-25) and therefore plunger 42 is at leastpartially retracted.

Reference is now made to FIG. 27, which is a sectional illustration ofthe drug mixing system of FIG. 1H following drug dilution.

As seen in FIG. 27 syringe adaptor element 50 and syringe 40 joinedthereto are pushed into engagement with forward facing portion 348 ofvial adaptor element 30.

Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage wallportion 346 of forward facing portion 348, thus ensuring that theengagement between syringe adaptor element 50 and portion 348 is secure.At this stage, spring 536 is in a compressed state, and housing element500 is pushed rearwardly by the pressure from forward facing portion348.

The rearward motion of housing element 500 causes the sharpened tip ofneedle 550 to pierce septa 502 and 350. As a result, needle 550partially extends through a hollow section of portion 348, and is influid flow engagement with vial 10 via bore 350 of neck portion 344 andvial puncturing spike 322 of main body element 302. Due to the fluidflow engagement between luer 44 of syringe 40 and needle 550 of syringeadaptor element 50, the syringe 40 is now in fluid flow engagement withvial 10. It is appreciated that when using the syringe adaptor elementdescribed in FIG. 9C, needle protector 560 at least partially collapses,thus exposing the needle 550.

At this stage, a user injects the fluid contained in syringe 40 intovial 10 via bore 350 of neck portion 344 and vial puncturing spike 322by inwardly pushing plunger 42 of syringe 40. A corresponding volume ofair escapes from vial 10 via membrane 336 and optional carbon clothfilter 340. It is appreciated that any drug containing aerosol isblocked by the membrane and any non-aerosolized drug vapor is adsorbedby the charcoal filter, thus protecting users and the environment fromcontamination.

Preferably, the user ensures that the drug contained in vial 10 is fullydissolved, and then draws at least part of the drug solution containedin vial 10 into syringe 40 by turning the system upside down andretracting plunger 42 (not shown). At this stage, a corresponding volumeof sterile air enters vial 10 via membrane 336 and optional carbon clothfilter 340.

In order to disengage syringe adaptor element 50 and forward facingportion 348, a user pushes slightly on arms 526 extending from sidesurfaces 524 of housing element 522, causing teeth 527 to move outwardand release a wall portion 346 of forward facing portion 348, thusdisconnecting the forward facing portion.

Throughout the engagement and disengagement process, septum 350 of vialadaptor element 30 and septum 502 of syringe adaptor element 50 arepushed into touching engagement by the biasing force of spring 536, thuspreventing exposure of the tip of needle 550 to the environment.

Reference is now made to FIG. 28, which is a sectional illustration ofthe drug mixing system of FIGS. 1K and 1L in a protected, ready fordelivery state, when syringe adaptor element 50 is covered by syringeprotection cover 80.

As seen in FIG. 28, syringe adaptor element 50 is preferably covered ata forward end thereof by syringe protection cover 80. At this stage,plunger 42 is preferably at least partially retracted with respect tosyringe 40, and the syringe contains a drug solution withdrawn from vial10 (FIG. 27).

The forwardmost circumference of main body portion 523 is preferablyseated in the recess formed by wall portions 806 and 810 of syringeprotection cover 80 and surface 804 of syringe cover element 80preferably engages a forward surface of septum 502.

It is appreciated that at this stage compression spring 536 is relaxedand the sharpened tip of needle 550 is preferably located between septa502 and 504. Preferably, surfaces 528 of teeth 527 of arms 526 engageforward facing surfaces on either side of intermediate portion 514 ofhousing element 500.

Reference is now made to FIG. 29, which is a partially pictorial,partially sectional illustration of the drug mixing system of FIGS. 1Mand 28 when ready for injection.

As seen in FIG. 29, syringe protection cover 80 has been removed fromsyringe adaptor element 50, and syringe adaptor element 50 and syringe40 joined thereto are pushed into engagement with cylindrical portion902 of infusion set adaptor element 90, while the infusion set adaptorelement 90 is connected to a side port of an intravenous cannula locatedat an injection site.

Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage arearward facing wall portion of cylindrical portion 902, thus ensuringthat the engagement between syringe adaptor element 50 and cylindricalportion 902 is secure. At this stage, spring 536 is in a compressedstate, and housing element 500 is pushed rearwardly by the pressure fromcylindrical portion 902.

The rearward motion of housing element 500 causes the sharpened tip ofneedle 550 to pierce septa 502 and 904. As a result, needle 550partially extends through bore 912 of infusion set adaptor element 90,and is therefore in fluid flow engagement with the injection site. Dueto the fluid flow engagement between luer 44 of syringe 40 and needle550 of syringe adaptor element 50, the syringe 40 is now in fluid flowengagement with the injection site. It is appreciated that when usingthe syringe adaptor element described in FIG. 9C, needle protector 560at least partially collapses, thus exposing the needle 550.

In order to disengage syringe adaptor element 50 and cylindrical portion902, a user pushes slightly on arms 526 extending from side surfaces 524of housing element 522, causing teeth 527 to move outward and release athe rearward facing wall portion of cylindrical portion 902, thusdisconnecting the cylindrical portion.

Reference is now made to FIG. 30, which is a partially pictorialpartially sectional illustration of the drug mixing system of FIGS. 1Mand 20 when ready for injection.

Preferably, receptacle 62 is connected via spike port adaptor element 60to an infusion set 92. The infusion set then connects to a standardintravenous cannula 94 such as a Venolit model commercially availablefrom Teva Medical Ltd. of Ashdod, Israel which is located in an infusionsite. Typically, prior to connection of spike port adaptor element 60 toinfusion set 92, sealing element 630 is removed, and infusion set 92 isconnected directly to tube 602.

Alternatively, infusion set 92 may be connected to a new receptacle, notcontaining a drug, in which case the drug solution is injected directlyinto the infusion set. If this option is selected, syringe adaptor 50having syringe 40 (FIG. 28) joined thereto is connected to port 93 aftersyringe protector cover 80 is removed, and the drug solution containedtherein is injected into the infusion line.

Preferably, surfaces 528 of teeth 527 of arms 526 snap to engage arearward facing wall portion of port 93, thus ensuring that theengagement between syringe adaptor element 50 and port 93 is secure. Atthis stage, spring 536 is in a compressed state, and housing element 500is pushed rearwardly by the pressure from port 93.

The rearward motion of housing element 500 causes the sharpened tip ofneedle 550 to pierce septum 502 and a sealing septum of port 93. As aresult, needle 550 partially extends into infusion set 92, and istherefore in fluid flow engagement with the injection site. Due to thefluid flow engagement between luer 44 of syringe 40 and needle 550 ofsyringe adaptor element 50, the syringe 40 is now in fluid flowengagement with the injection site.

In order to disengage syringe adaptor element 50 and port 93, a userpushes slightly on arms 526 extending from side surfaces 524 of housingelement 522, causing teeth 527 to move outward and release a rearwardfacing wall portion of port 93, thus disconnecting the port.

Reference is now made to FIGS. 31A, 31B, 31C, 31D, 31E, 31F, 31G, 31H,31I 31J and 31L which are simplified pictorial illustrations of variousstages of assembly and typical use of a drug mixing system constructedand operative in accordance with another preferred embodiment of thepresent invention.

FIG. 31A shows a spike port adaptor element 1030, as describedhereinbelow with reference to FIGS. 34-35, being inserted into a spikeport 1031 in a receptacle 1032 containing a fluid. Preferably, a luerconnector of spike port adaptor element 1030 is sealed by a luer coverelement 1034.

Typically, receptacle 1032 comprises a bag, and the fluid containedtherein is sterile salt solution, water, or any other suitable sterilesolution or pure fluid.

As shown in FIG. 31B, a luer-equipped hypodermic syringe 1040, having aplunger 1042 and a luer tip 1044, is connected to a syringe port of anadaptor assembly 1050, which is described hereinbelow with reference toFIGS. 36 and 44-45B. Preferably, the syringe port is defined by astopcock 1052 which is described hereinbelow with reference to FIGS.37-38B and includes a removable protection cap 1054. FIG. 46 shows asectional view of the drug mixing system at this stage.

Typically, plunger 1042 of syringe 1040 is pushed fully inward beforethe syringe is connected to the syringe port of stopcock 1052.

FIG. 31C shows spike port adaptor element 1030 and receptacle 1032joined thereto being connected to a receptacle adaptor subassembly 1056of adaptor assembly 1050. Subassembly 1056 is described hereinbelow withreference to FIGS. 39-40B. Preferably, stopcock 1052 is in an operativeorientation which enables fluid flow between receptacle adaptorsubassembly 1056 and syringe 1040. FIG. 47 shows a sectional view of thedrug mixing system at this stage.

As seen in FIG. 31D, a vial 1060, including a top portion 1062 and aneck portion 1063, is pushed into engagement with a vial adaptorsubassembly 1058 of adaptor assembly 1050. Top portion 1062 of vial 1060preferably has a septum 1064 sealingly seated therein. Subassembly 1058is described hereinbelow with reference to FIGS. 41-42B.

Alternatively, if a small vial 1066 is used, small vial 1066 is pushedinto engagement with a vial head adaptor element 1068, which isdescribed hereinbelow with reference to FIGS. 32-33, as shown in FIG.31E, and is then pushed into engagement with vial adaptor subassembly1058. Vials 1060 and 1066 typically contain a drug in soluble powderform, in a solution or in other suitable form. FIG. 48 shows a sectionalview of the drug mixing system at this stage.

It is appreciated that stopcock 1052, receptacle adaptor subassembly1056 and vial adaptor subassembly 1058 are preferably enclosed in ahousing element 1070 of adaptor assembly 1050, which is describedhereinbelow with reference to FIGS. 43A-43B.

It will be appreciated by persons skilled in the art that the assemblysteps shown in FIGS. 31C-31E may be performed in any suitable sequence.

As seen in FIG. 31F, a user retracts plunger 1042 while receptacle 1032is upright and vial 1060 lies therebelow, thus at least partiallyfilling syringe 1040 with fluid drawn from receptacle 1032. Theoperative orientation of stopcock 1052 enables this fluid flow fromreceptacle 1032 to syringe 1040 via spike port adaptor element 1030,receptacle adaptor subassembly 1056 and stopcock 1052 in a manner thatensures that the fluid remains sterile, and that the user is not exposedthereto. FIG. 49 shows a sectional view of the drug mixing system atthis stage.

The user then rotates a handle 1080 of stopcock 1052 to enable fluidflow between syringe 1040 and vial adaptor subassembly 1058, havingjoined thereto vial 1060, as shown in FIG. 31G.

When the syringe 1040 and vial 1060 are in fluid flow engagement, theuser pushes plunger 1042 inward, thus injecting the fluid contained insyringe 1040 into vial 1060 and dissolving the drug contained therein.FIG. 50 shows a sectional view of the drug mixing system at this stage.

As seen in FIG. 31H, the user then shakes the drug mixing system of FIG.31G to ensure that the drug in vial 1060 is fully dissolved and that theresulting solution is homogenous.

As seen in FIG. 31I, the user turns the system upside down, so that thevial 1060 faces upward, and then retracts plunger 1042, thus drawing atleast part of the solution from vial 1060 into syringe 1040. FIG. 51shows a sectional view of the drug mixing system at this stage.

It will be appreciated by those skilled in the art that at this stagethe drug mixing system of the present invention is preferably held suchthat vial 1060 lies above syringe 1040, to allow smooth flow of thefluid from vial 1060 to syringe 1040 via vial adaptor subassembly 1058and stopcock 1052.

As shown in FIG. 31J, handle 1080 of stopcock 1052 is oriented to enableflow of fluid between syringe 1040 and receptacle 1032. The user thenpushes plunger 1042 of syringe 1040 inward, thus injecting the drugsolution into receptacle 1032 and further diluting it prior to infusioninto a patient. FIG. 52 shows a sectional view of the drug mixing systemat this stage.

Subsequently, spike port adaptor element 1030, having receptacle 1032joined thereto, is disconnected from adaptor assembly 1050, whichremains connected to vial 1060 as shown in FIG. 31K.

As seen in FIG. 31L, if some of the drug solution is left in vial 1060,vial 1060 and adaptor assembly 1050 joined thereto may be stored in asuitable facility for further use. It is appreciated that at this stagesyringe 1040 remains connected to the syringe port of stopcock 1052 ofadaptor assembly 1050. FIG. 53 is a sectional view of the drug mixingsystem at this stage.

The structure of elements of the drug mixing system of FIGS. 31A-31L isdescribed hereinbelow with reference to FIGS. 32-43B.

Reference is now made to FIG. 32, which is a simplified pictorialillustration of a vial head adaptor element 1068 which forms part of thedrug mixing system of FIGS. 31A-31L and to FIG. 33 which is a sectionalillustration taken along section lines XXXIII-XXXIII in FIG. 32.

As seen in FIG. 32, vial head adaptor element 1068 is preferably aside-to-side symmetric integrally formed element which is preferablyinjection molded of plastic.

Vial head adaptor element 1068 preferably includes a main body portion1200 which is generally cylindrical and has a central axis 1201. Aninner cylindrical surface 1202 of main body portion 1200 preferably hasfour arms 1204 extending therefrom, each arm 1204 being arranged atgenerally right angles with respect to its neighboring arms.

Each of arms 1204 terminates at an upper end thereof, in the sense ofFIG. 31A, in an inwardly facing generally triangular tooth 1206 having aupwardly facing inclined surface 1208 and a bottom-facing engagementsurface 1210 extending generally perpendicular to arm 1204.

At the bottom of vial head adaptor element 1068, there are formed fourinwardly protruding surfaces 1212, extending generally perpendicular toinner surface 1202 of main body portion 1200. Each of neighboringsurfaces 1212 is preferably arranged at a generally right angle withrespect to its neighboring surfaces 1212. Surfaces 1212 and arms 1204are rotationally offset from one another about axis 1201.

Reference is now made to FIG. 34, which is a simplified pictorialillustration of spike port adaptor element 1030 which forms part of thedrug mixing system of FIGS. 31A-31L and to FIG. 35 which is a sectionalillustration taken along section lines XXXV-XXXV in FIG. 34.

Spike port adaptor element 1030 preferably comprises a hollow flexibleplastic tube 1302 having associated therewith a standard clamp 1304,which is commercially available from various manufacturers such asQuosina of Italy.

At a forward end thereof, tube 1302 is connected to a tube port 1305 ofa hollow spike element 1306 which is preferably formed of plastic. Spikeelement 1306 preferably includes a main body portion 1307 which definesat a forward end thereof a spike 1308 which includes an aperturecommunicating with an axially extending bore 1310 and an additional bore1312 which extends partially through main body portion 1307 andcommunicates with a top portion of bore 1310, thus facilitating completepriming before drug injection.

Rearward of spike 1308, main body portion 1307 defines a generallycircular planar protrusion 1314 adapted to define the location at whicha user grips the spike.

The interior of tube 1302 is in fluid flow communication with bore 1312via tube port 1305. Bore 1310 preferably terminates in an aperturelocated in spike 1308 of main body portion 1307, and fully extendsthrough the body portion 1307.

Main body portion 1307 preferably terminates in a connection port 1318which is adapted to connect spike port adaptor element 1030 toreceptacle adaptor subassembly 1056. Connection port 1318 preferablysealingly accommodates a generally circular septum 1320 on a seat 1322.Septum 1320 preferably engages the rear end of bore 1310, thus sealingthe rear end of the bore.

Forward of connection port 1318, there is formed on main body portion1307 a circumferential protrusion 1324, forward of which is formed anadditional circumferential protrusion 1326, having an outercircumference which is slightly larger than that of protrusion 1324.Protrusions 1324 and 1326 are adapted to limit the movement of spikeport adaptor element 1030 when it is connected to receptacle adaptorsubassembly 1056.

A luer connector 1330 is preferably attached to a rear end of tube 1302.Luer connector 1330 preferably includes at a rearwardmost end thereof anarrow hollow port section 1332, forward of which there is formed aconnecting tube portion 1334 and a hollow neck portion 1336 whichconnects port section 1330 to tube 1302. Preferably, luer connector 1330is sealed by luer cover element 1034.

It is appreciated that spike port adaptor element 1030 may alternativelybe identical to spike port adaptor element 630 described hereinabovewith reference to FIGS. 10-11B.

Reference is now made to FIG. 36, which is a simplified exploded viewillustration of adaptor assembly 1050 which forms part of the drugmixing system of FIGS. 31A-31L.

As seen with particular clarity in FIG. 36, adaptor assembly 1050includes vial adaptor subassembly 1058, onto which is placed ahydrophobic membrane 1402, above which is optionally seated a carboncloth filter 1404. Vial adaptor subassembly 1058 is connected at aforward portion thereof to a vial port 1082 of stopcock 1052, whichadditionally includes a syringe port 1084 adapted for engagement withluer 1044 of syringe 1040. Stopcock 1052 additionally includes areceptacle port 1086 which is adapted for connection to a rearconnection element 1406 of receptacle adaptor subassembly 1056.

Preferably, when syringe 1040 is not connected to the syringe port ofstopcock 1052, the syringe port 1084 is sealed by protection cap 1054.

A needle holding element 1408 is preferably seated within rearconnection element 1406 and supports a needle 1410. A forward portion ofneedle 1410 is preferably protected by a flexible latex needleprotection element 1412. Receptacle adaptor subassembly 1056 connects ata rearward end thereof to rear connection element 1406, enclosing needleholding element 1408, needle 1410 and needle protection element 1412.

The forward portion of vial adaptor subassembly 1058 as well as stopcock1052 and the rear portion of receptacle adaptor subassembly 1056 arelocated within housing element 1070. However, a handle 1080 of stopcock1052 protrudes from housing element 1070, thus enabling a user to changethe operative orientation of the stopcock 1052 and thereby switch thefluid flow pathway.

Reference is now made to FIG. 37, which is a simplified pictorialillustration of stopcock 1052 which forms part of the adaptor assemblyof FIG. 36 and to FIGS. 38A and 38B, which are sectional illustrationstaken along respective section lines XXXVIIIA-XXXVIIIA andXXXVIIIB-XXXVIIIB in FIG. 37.

Stopcock 1052, as noted hereinabove, has a vial port 1082, a syringeport 1084 and a receptacle port 1086, all of which are defined in ahousing portion 1090. User operable handle 1080 is fixed to a pathwaydefining element 1092, which defines a three-way direction pathway, asseen with particularity in FIG. 38B. Selectable rotational orientationof handle 1080 enables any two of ports 1082, 1084 and 1086 to be placedin mutual fluid communication. Stopcock 1052 is commercially availablefrom Elcam Ltd. of Baram, Israel.

Reference is now made to FIG. 39, which is a simplified pictorialillustration of receptacle adaptor subassembly 1056 which forms part ofthe adaptor assembly of FIG. 36 and to FIGS. 40A and 40B, which aresectional illustrations taken along respective section lines XLA-XLA andXLB-XLB in FIG. 39.

As seen in FIGS. 39-40B, receptacle adaptor subassembly 1056 includes amain body element 1600 which is arranged generally about an axis 1601.Main body element 1600 is preferably integrally formed of plastic, andis preferably side-to-side symmetric about axis 1601. Main body element1600 preferably includes a generally cylindrical base portion 1602terminating in a rear portion 1604.

Top and bottom generally concave wall portions 1606 are formed at aforward end of base portion 1602, each wall portion 1606 defining on anouter surface thereof an outwardly facing axially extending rib 1608,which extends from a forwardmost end of each of wall portions 1606 andalong base portion 1602.

A connection surface 1610 extending transversely from side surfaces 1612of base portion 1602 connects an outwardly extending arm 1614 to eachside surface 1612. Each arm 1614 preferably has a generally square rearportion 1616, formed rearwardly of connection surface 1610, and has aradially extending outwardly facing protrusion 1618 formed thereon.Protrusion 1618 preferably extends onto an outer surface of a generallyrectangular forward portion 1620 of each of arms 1614, which extendsforwardly of connection surface 1610.

An inwardly facing generally triangular tooth 1622 is formed adjacent atop end of each of forward portions 1620. Each tooth 1622 preferablyincludes a forwardly facing inclined surface 1624 and a rearwardlyfacing engagement surface 1626.

Rear portion 1604 preferably includes a transversely extending generallycircular portion 1630 which forms a base for ribs 1608 and whichterminates at a rear end thereof in an axially extending generallycylindrical wall portion 1632.

Wall portion 1632 preferably defines on a top and bottom surface thereofa small generally rectangular window 1634, and two forwardly facingslots 1636 which are formed on either side of window 1634. Two generallysymmetric side-facing tabs 1638 are formed on side surfaces 1640 of wallportion 1632, each tab 1638 being formed forwardly of a generallyrectangular forwardly facing slot 1642.

Rear connection element 1406 preferably includes a forward disk 1652defining a central bore 1654. Disk 1652 preferably functions as aterminating wall for a forward facing cylindrical portion 1656. Rearwardof disk 1652 there is preferably formed a rear portion 1658, having anarrow bore 1660 extend therethrough. Bore 1660 preferably widens towardthe rear end of rear portion 1658, thus enabling rear portion 1658 toconnect to an appropriate port. Preferably, two generally symmetric tabs1662 are formed on top and bottom surfaces of rear portion 1658.Cylindrical portion 1656 preferably has an outer circumference that isslightly smaller than that of wall portion 1632, and is located therein.

Needle holding element 1408 preferably supports needle 1410 on agenerally circular disk portion 1672. Needle 1410 extends axiallythrough base portion 1602 of main body element 1600 and through bore1660 of rear connection element 1650. Disk portion 1672 is preferablyseated in cylindrical portion 1656, and is locked into cylindricalportion 1656 by portion 1630.

Reference is now made to FIG. 41, which is a simplified pictorialillustration of vial adaptor subassembly 1058 which forms part ofadaptor assembly 1050 of FIG. 36 and to FIGS. 42A and 42B, which aresectional illustrations taken along respective section lines XLIIA-XLIIAand XLIIB-XLIIB in FIG. 41.

As seen in FIGS. 41-42B, vial adaptor subassembly 1058 comprises a mainbody element 1702 arranged generally about an axis 1703. Main bodyelement 1702 is preferably integrally formed and preferably injectionmolded of plastic.

Main body element 1702 is preferably side-to-side symmetric about axis1703, and preferably includes a rear portion 1704, which is generallycylindrical and terminates in a forward wall 1706. Rear portion 1704comprises a forward base section 1708, preferably having fourtransversely extending outwardly facing protrusions 1709 extendtherefrom, each protrusion being arranged at generally right angles withrespect to its neighboring protrusions.

Rearward of base section 1708 there are formed four tabs 1710 eachhaving a rectangular window 1712. Rearward of rectangular windows 1712and on an inner surface 1714 of each of tabs 1710 there are preferablyformed two radially extending inwardly facing protrusions 1716 eachhaving an inclined surface. Protrusions 1716 preferably terminate at aforward end thereof in an inwardly facing transversely extendingprotrusion 1718. Rearward of protrusions 1716, each of tabs 1710preferably includes an outwardly tapered portion 1720.

A hollow vial puncturing spike 1722 extends rearwardly from a rearwardsurface 1724 of forward wall 1706, and is surrounded by base section1708 and by tabs 1710. Rearward surface 1724 additionally includes acircular cylindrical protrusion 1725, surrounding puncturing spike 1722.Two axially extending bores 1726 and 1727 extend through vial puncturingspike 1722.

Forward of forward wall 1706 of rear portion 1704 there is formed anintermediate portion which is formed of two generally rectangularsurfaces 1728, and which includes an axial tubular portion 1730 having abore 1731 extend therethrough, bore 1731 being in fluid flow engagementwith bore 1726 of hollow vial puncturing spike 1722.

On the top rectangular surface 1728 and slightly recessed with respectthereto there is formed a plastic membrane support surface 1732, havingformed thereon a plurality of generally evenly distributed sphericalprotrusions 1734, which are adapted to support hydrophobic membrane 1402and prevent it from excessive inflation and from cracking. Membrane 1402is adapted to allow free passage of air to and from main body element1702, but to prevent passage of liquid and air borne particles,microorganisms and aerosol. A preferred membrane 1402 is Model VersaporR 0.2 Micron which is commercially available from Pall Corporation ofNew York, U.S.A. Membrane 1402 is in fluid flow engagement with vialpuncturing spike via bore 1727 and via a recess 1737 formed in toprectangular surface 1728.

A rim 1738 surrounding support surface 1732 is adapted to support acarbon cloth filter 1404 and maintain it in a raised position above andspaced from membrane 1402. Carbon filter 1404 is adapted to preventtoxic vapors from escaping from main body element 1702, thus protectingusers. A preferred carbon cloth filter 1404 is Model No. Zorflex EMIwhich is commercially available from Charcoal Cloth International Ltd.of Houghton-le-Spring, England.

Rectangular surfaces 1728 of the intermediate portion terminate at aforward end thereof in a forward facing cylindrical portion 1748, havinga bore 1750 extend therethrough. Preferably, bore 1750 is a continuationof tubular portion 1730 of the intermediate portion.

It is appreciated that the functionalities of membrane 1402 and carboncloth filter 1404, to allow free passage of air into the drug mixingsystem while preventing passage thereinto of liquid and air-borneparticles, microorganisms and aerosol and preventing toxic vapors fromescaping from the drug mixing system, may be incorporated, using similarelements, into spike port adaptor element 1030 or receptacle adaptorsubassembly 1056.

Reference is now made to FIGS. 43A and 43B, which are simplifiedpictorial illustrations of the housing element 1070 which forms part ofthe adaptor assembly 1050 of FIG. 36 in closed and open orientations,respectively.

As seen in FIGS. 43A and 43B, housing element 1070 is preferablyintegrally formed about an axis 1800 and includes a top housing portion1801 and a bottom housing portion 1802. Preferably, housing portions1801 and 1802 are side-to-side symmetric about axis 1800. Preferably,each of housing portions 1801 and 1802 includes a semi-cylindricalforward portion 1804 and a semi-cylindrical rearward portion 1806.

Top housing portion 1801 includes an inwardly recessed portion 1808including a generally round aperture 1810 which extends forwardly intoan elongate aperture 1812. Rearward of aperture 1810 there is preferablyformed an elongate protrusion 1814. Preferably, apertures 1810 and 1812lie below handle 1080 of stopcock 1052 when adaptor assembly 1050 isassembled.

Bottom housing portion 1802 includes an inwardly recessed portion 1816which is generally symmetrical to recessed portion 1808 of top housingportion 1801, and which includes a central generally round aperture1818. Two elongate protrusions 1820 are formed on either side ofaperture 1818, such that rearward protrusion 1820 is generallysymmetrical to protrusion 1814 of top housing portion 1801. Preferably,a bottom portion of pathway defining element 1090 of stopcock 1052extends through aperture 1818 when adaptor assembly 1050 is assembled.

Top housing portion 1801 includes at forward and rearward ends thereofoutwardly extending fingers 1822 terminating in a generally triangularteeth 1824 which include inclined outwardly facing surfaces 1826 andengagement surfaces 1828. Bottom housing portion 1802 preferablyincludes at forward and rearward ends thereof two generally rectangularwindows 1830 which are placed generally below fingers 1822 and areadapted to engage engagement surfaces 1828 of fingers 1822 when housingelement 1070 is assembled.

An inner surface 1834 of housing element 1070 preferably includes at arearward end thereof a circumferential recess 1836 which is adapted toengage protrusions 1709 of rear portion 1704 of vial adaptor subassembly1058. An outer surface of housing element 1070 which lies above recess1836 preferably includes an outwardly facing protrusion 1840 whichprotrudes out of cylindrical forward portion 1804.

Preferably, side surfaces of top housing portion 1801 and bottom housingportion 1802 include generally parallel generally rectangular slots1842, through which syringe port 1084 of stopcock 1052 extends whenadaptor assembly 1050 is assembled.

Reference is now made to FIG. 44, which is a simplified assembledpictorial illustration of the adaptor assembly of FIG. 36 and to FIGS.45A and 45B, which are sectional illustrations taken along respectivesection lines XLVA-XLVA and XLVB-XLVB in FIG. 44.

As seen in FIGS. 44-45B, rear portion 1704 of vial adaptor subassembly1058 extends from a rear portion of housing element 1070. Vialpuncturing spike 1722 preferably extends out of housing element 1070,and is accessible for connection of vial 1060 or of vial 1066 (FIG. 31E)thereto.

Preferably, circumferential recess 1836 of inner surface 1834 of housingelement 1070 engages protrusions 1709 of rear portion 1704 of vialadaptor subassembly 1058. Preferably, forward facing cylindrical portion1748 engages vial port 1082 of stopcock 1052.

A forward portion of main body element 1600 of receptacle adaptorsubassembly 1056 preferably extends from a forward portion of housingelement 1070 of adaptor assembly 1050, and surrounds needle 1410enclosed in needle protection element 1412. Main body element includingneedle 1410 and needle protection cover 1412 is preferably accessiblefor connection of spike port adaptor element 1030 (FIGS. 34-35) thereto.

Preferably, rear portion 1658 of rear connection element 1406 engagesreceptacle port 1086 of stopcock 1052. A rear end of needle 1410 atleast partially extends through bore 1660 such that needle 1410 is influid flow communication with receptacle port 1086.

Syringe port 1084 of stopcock 1052 preferably extends from housingelement 1070 through slots 1842 formed in side surfaces thereof.Preferably, pathway defining element 1092 extends from apertures 1810and 1812 of top housing portion 1801, and a bottom portion of stopcock1052 extends through aperture 1818 of bottom housing element.

Housing element 1070 is preferably assembled such that top housingportion 1801 and bottom housing portion 1802 are connected by engagementof engagement surfaces 1828 of teeth 1824 of top housing portion 1801and windows 1830 of bottom housing portion 1802.

Reference is now made to FIG. 46, which is a sectional illustration ofthe drug mixing system of FIG. 31B during attachment of syringe 1040 tothe adaptor assembly 1050 of FIGS. 44-45B.

As seen in FIG. 46, luer tip 1044 of syringe 1040 is attached to syringeport 1084 of stopcock 1052. At this stage, handle 1080 of stopcock 1052is positioned such that fluid can flow from receptacle port 1086 tosyringe 1040 thereof. It is appreciated that at this stage plunger 1042of syringe 1040 is preferably pushed fully inward in the syringe.

Reference is now made to FIG. 47, which is a sectional illustration ofthe drug mixing system of FIG. 31C during attachment of spike portadaptor element 1030 and receptacle 1032 of FIG. 31A to the receptacleadaptor subassembly 1056 of the adaptor assembly 1050 of FIG. 46.

As seen in FIG. 47, spike port adaptor element 1030, having receptacle1032 joined thereto, is connected to receptacle adaptor subassembly 1056of adaptor assembly 1050.

Spike 1308 is preferably previously inserted into spike port 1031 ofreceptacle 1032, such that bore 1310 of spike element 1306 engages fluidcontent of receptacle 1032. Connection port 1318 of spike port adaptorelement 1030 engages wall portions 1606 and base portion 1602 of mainbody element 1600 of receptacle adaptor subassembly 1056.

Connection port 1318 is preferably locked into connection withreceptacle adaptor subassembly 1056 by engagement of engagement surfaces1626 of forward portions 1620 of arms 1614 (FIG. 40B) and a rearwardfacing wall portion of connection port 1318.

Preferably, needle 1410 punctures needle protection cover 1412 andseptum 1320, resulting in a change to the structure of the needleprotection cover. At this stage, receptacle 1032 is in fluid flowcommunication with syringe 1040 via bore 1310 of spike 1308 of spikeport adaptor element 1030, needle 1410, bore 1660 and receptacle portand syringe port 1084 of stopcock 1052.

Reference is now made to FIG. 48, which is a sectional illustration ofthe drug mixing system of FIG. 31D during attachment of vial 1060 tovial adaptor subassembly 1058 of the adaptor assembly 1050 of FIG. 47.

Vial 1066 and vial head adaptor element 1068 joined thereto (FIG. 1E) orvial 1060 is preferably pushed into engagement with vial puncturingspike 1722 of vial adaptor subassembly 1058.

Typically, vial puncturing spike 1722 of vial adaptor subassembly 1058punctures septum 1064 located inside top portion 1062 of vial 1060, thusenabling fluid flow between the main body of vial 1060 and cylindricalportion 1748 of main body element 1702 of vial adaptor subassembly 1058.Preferably, puncturing of septum 1064 releases any vacuum in vial 1060by entrance of air into vial 1060 through carbon filter 1404 (FIG. 42B)and membrane 1402 (FIG. 42B).

Engagement between vial adaptor subassembly 1058 and vial 1060 ispreferably maintained by snap engagement of protrusions 1716 and 1718(FIGS. 42A and 42B) of rear portion 1704 of main body element 1702 witha neck portion 1063 of vial 1060. The engagement of protrusions 1716 and1718 with neck portion 1063 ensures that vial adaptor subassembly 1058is latched onto vial 1060 and cannot be removed therefrom. Tabs 1710 andoutwardly tapered portions 1720 generally surround top portion 1062 andneck portion 1063 of vial 1060.

At this stage, the main body of vial 1060 is in fluid flow communicationwith syringe port 1084 via vial puncturing spike 1722, bore 1750 ofcylindrical portion 1748 and vial port 1082 of stopcock 1052.

Reference is now made to FIG. 49, which is a sectional illustration ofthe drug mixing system of FIGS. 31F and 48 during fluid drawing fromreceptacle 1032 into syringe 1040.

At this stage, plunger 1042 of syringe 1040 is preferably retracted,thus drawing fluid from receptacle 1032 into syringe 1040. Fluid drawnfrom receptacle 1032 reaches syringe 1040 via bore 1310 of spike 1308 ofspike port adaptor element 1030, needle 1410, bore 1660 of receptacleadaptor subassembly 1056, receptacle port 1086, pathway defining element1092, syringe port 1084 and luer tip 1044.

Reference is now made to FIG. 50, which is a sectional illustration ofthe drug mixing system of FIGS. 31G and 48 during injection of fluidfrom syringe 1040 into vial 1060.

Initially, the user rotates handle 1080 of stopcock 1052, thus bringingsyringe port 1084 into fluid flow engagement with vial port 1082.

Preferably, the user pushes plunger 1042 of syringe 1040 inwardly withrespect to syringe 1040, resulting in injection of fluid from syringe1040 to vial 1060, thus dissolving the drug contained in the vial. Thefluid injected from syringe 1040 flows to vial 1060 via luer tip 1044 ofsyringe 1040, syringe port 1084, pathway defining element 1092, vialport 1082, bore 1750 of cylindrical portion 1748 and vial puncturingspike 1722.

The user preferably shakes the drug mixing system of FIG. 50 as shown inFIG. 31H, in order to ensure that the drug contained in vial 1060 isfully dissolved, and that the drug solution is homogenous.

Reference is now made to FIG. 51, which is a sectional illustration ofthe drug mixing system of FIGS. 31I and 48 during drawing of fluid fromvial 1060 into syringe 1040.

At this stage, the user positions the system such that vial 1060 is ontop, and preferably draws at least part of the drug solution containedin vial 1060, by at least partially retracting plunger 1042 of syringe1040. The fluid drawn from vial 1060 flows into syringe 1040 via vialpuncturing spike 1722, bore 1750 of cylindrical portion 1748, vial port1082, pathway defining element 1092 and syringe port 1084 of stopcock1052 and luer tip 1044 of syringe 1040.

Reference is now made to FIG. 52, which is a sectional illustration ofthe drug mixing system of FIGS. 31J and 48 during injection of fluidfrom syringe 1040 into receptacle 1032.

At a first stage, the user rotates handle 1080 of stopcock 1052,resulting in syringe port 1084 being in fluid flow engagement with vialport 1082.

Subsequently, plunger 1042 of syringe 1040 is preferably pushed inwardwith respect to the main body portion of the syringe. The inwarddisplacement of plunger 1042 causes injection of fluid from syringe 1040into receptacle 1032. Fluid drawn from syringe 1040 reaches receptacle1032 via luer tip 1044, syringe port 1084, pathway defining element1092, receptacle port 1086 of stopcock 1052, bore 1660 of receptacleadaptor subassembly 1056, needle 1410 and bore 1310 of spike 1308 ofspike port adaptor element 1030.

Reference is now made to FIG. 53, which is a sectional illustration ofthe drug mixing system of FIG. 31L when ready for storage.

As shown in FIG. 53, spike port adaptor element 1030 (FIGS. 34-35) andreceptacle 1032 joined thereto are disconnected from receptacle adaptorsubassembly 1056 of adaptor assembly 1050. Typically, spike port adaptorelement 1030 is disconnected from receptacle adaptor subassembly 1056 byslightly pushing arms 1614 extending from side surfaces 1612 (FIGS.39-40B) of base portion 1602, causing teeth 1620 to move outward andrelease the rearward facing wall portion of connection port 1318 (FIGS.34-35), thus disconnecting the connection port. Typically, needle 1410is released from connection port 1318, and needle protection cover 1412is deployed and once again fully encloses needle 1410, thus preventingliquid spill and aerosol spray.

Adaptor assembly 1050, including vial adaptor subassembly 1058, stopcock1052, receptacle adaptor subassembly 1056 and housing element 1070, ispreferably stored in a suitable cooling facility. During coolingthereof, adaptor assembly is preferably connected to syringe 1040,having plunger 1042 fully pushed inward, and to vial 1060 containing adrug solution therein. Typically, pathway defining element 1092 ofstopcock 1052 connects receptacle port 1086 to syringe port 1084 at thisstage.

Reference is now made to FIGS. 54A, 54B, 54C, 54D, 54E, 54F, 54G and 54Hwhich are simplified pictorial illustrations of various stages ofassembly and typical use of a drug mixing system constructed andoperative in accordance with yet another preferred embodiment of thepresent invention.

FIG. 54A shows a spike port adaptor element 2010, as describedhereinbelow with reference to FIGS. 57-58, being inserted into a spikeport 2011 in a receptacle 2012 containing a fluid. Preferably, a luerconnector of spike port adaptor element 2010 is sealed by a luer coverelement 2014.

Typically, receptacle 2012 comprises a bag, and the fluid containedtherein is sterile salt solution, water, or any other suitable sterilesolution or pure fluid.

As seen in FIG. 54B, a vial 2020, including a top portion 2022 and aneck portion 2023, is pushed into engagement with a vial adaptorsubassembly 2044 of adaptor assembly 2040. Top portion 2022 of vial 2020preferably has a septum 2024 sealingly seated therein. Subassembly 2044is described hereinbelow with reference to FIGS. 60-61B.

Alternatively, if a small vial 2026 is used, small vial 2026 is pushedinto engagement with a vial head adaptor element 2030 which is describedhereinbelow with reference to FIGS. 55-56 as shown in FIG. 54C, and isthen pushed into engagement with vial adaptor subassembly 2044. Vials2020 and 2026 typically contain a drug in soluble powder form, in asolution or in other suitable form. FIGS. 67A and 67B show a sectionalview of the drug mixing system at this stage.

FIG. 54D shows spike port adaptor element 2010 and receptacle 2012joined thereto, being connected to a receptacle adaptor subassembly 2046of adaptor assembly 2040, which is described hereinbelow with referenceto FIGS. 62-63B.

It is appreciated that receptacle adaptor subassembly 2046 and vialadaptor subassembly 2044 are preferably enclosed in a housing element2050 of adaptor assembly 2040, which is described hereinbelow withreference to FIGS. 64A-64B.

It is appreciated by persons skilled in the art that the assembly stepsshown in FIGS. 54A-54D may be performed in any suitable sequence.

As seen in FIG. 54E, a user holds receptacle 2012 upright and squeezesthe receptacle, thus at least partially filling vial 2020 with fluidsqueezed out of receptacle 2012. This flow of fluid ensures that thefluid remains sterile, and that the user is not exposed thereto.

As seen in FIG. 54F, the user then shakes the drug mixing system of FIG.54E to ensure that the drug in vial 2020 is fully dissolved and that theresulting solution is homogenous.

As seen in FIG. 54G, the user reverses the direction of the receptacle2012, such that it is now facing downward, and then squeezes thereceptacle. Squeezing of the receptacle 2012 causes the drug solutioncontained in vial 2020 to be drawn into the receptacle, thus furtherdiluting the solution. The user preferably repeats this action untilvial 2020 is empty, thus diluting the entire content of the vial in asingle receptacle.

As shown in FIG. 54H, spiked receptacle adaptor element 2010 havingreceptacle 2012 joined thereto is disconnected from adaptor assembly2040, which remains connected to vial 2020. It is appreciated that atthis stage adaptor assembly 2040 and vial 2020 may be disposed of.

The structure of elements of the drug mixing system of FIGS. 54A-54H isdescribed hereinbelow with reference to FIGS. 55-64B.

Reference is now made to FIG. 55, which is a simplified pictorialillustration of a vial head adaptor element 2030 which forms part of thedrug mixing system of FIGS. 54A-54H and to FIG. 56 which is a sectionalillustration taken along section lines LVI -LVI in FIG. 55.

As seen in FIG. 55, vial head adaptor element 2030 is preferably aside-to-side symmetric integrally formed element which is preferablyinjection molded of plastic.

Vial head adaptor element 2030 preferably includes a main body portion2200 which is generally cylindrical and has a central axis 2201. Aninner cylindrical surface 2202 of main body portion 2200 preferably hasfour arms 2204 extending therefrom, each arm 2204 being arranged atgenerally right angles with respect to its neighboring arms.

Each of arms 2204 terminates at an upper end thereof, in the sense ofFIG. 54C, in an inwardly facing generally triangular tooth 2206 having aforwardly facing inclined surface 2208 and a bottom-facing engagementsurface 2210 extending generally perpendicular to arm 2204.

At bottom surface of vial head adaptor element 2030, there are formedfour inwardly protruding surfaces 2212, extending generallyperpendicular to inner surface 2202 of main body portion 2200. Each ofneighboring surfaces 2212 is preferably arranged at a generally rightangle with respect to its neighboring surfaces 2212. Surfaces 2212 andarms 2204 are rotationally offset from one another about axis 2201.

Reference is now made to FIG. 57, which is a simplified pictorialillustration of spike port adaptor element 2030 which forms part of thedrug mixing system of FIGS. 54A-54H and to FIG. 58 which is a sectionalillustration taken along section lines LVIII-LVIII in FIG. 57.

Spike port adaptor element 2010 preferably comprises a hollow flexibleplastic tube 2302 having associated therewith a standard clamp 2304,which is commercially available from various manufacturers, such asQosina of Italy.

At a forward end thereof, tube 2302 is connected to a tube port 2305 ofa hollow spike element 2306 which is preferably formed of plastic. Spikeelement 2306 is preferably formed of a main body portion 2307 whichpreferably defines at a forward end thereof a spike 2308, having formedtherein an aperture communicating with an axially extending bore 2310and an additional bore 2312 which extends partially through main bodyportion 2307 and communicates with a top portion of bore 2310.

Rearward of spike 2308, main body portion 2307 defines a generallycircular planar protrusion 2314 adapted to define the location at whicha user grips the spike.

The interior of tube 2302 is in fluid flow communication with bore 2312via tube port 2305. Bore 2310 preferably terminates in an aperturelocated in spike 2308 of main body portion 2307 and fully extendsthrough the main body portion.

Main body portion 2307 preferably terminates in a connection port 2318which is adapted to connect spike port adaptor element 2010 toreceptacle adaptor subassembly 2046. Connection port 2318 preferablysealingly accommodates a generally circular septum 2320 on a seat 2322.Septum 2320 preferably engages the rear end of bore 2310, thus sealingthe rear end of the bore.

Forward of connection port 2318, there is formed on main body portion2307 a circumferential protrusion 2324, forward of which is formed anadditional circumferential protrusion 2326, having an outercircumference which is slightly larger than that of protrusion 2324.Protrusions 2324 and 2326 are adapted to limit the movement of spikeport adaptor element 2010 when it is connected to receptacle adaptorsubassembly 2044.

A luer connector 2330 is preferably attached to a rear end of tube 2302.Luer connector 2330 preferably includes at a rearwardmost end thereof anarrow hollow port section 2332, forward of which there is formed aconnecting tube portion 2334 and a hollow neck portion 2336 which isadapted to connect luer connector 2330 to tube 2302. Preferably, luerconnector 2330 is sealed by luer cover element 2014.

It is appreciated that spike port adaptor element 2010 may alternativelybe identical to spike port adaptor element 630 described hereinabovewith reference to FIGS. 10-11B.

Reference is now made to FIG. 59, which is a simplified exploded viewillustration of adaptor assembly 2040 which forms part of the drugmixing system of FIGS. 54A-54H.

As seen with particular clarity in FIG. 59, adaptor assembly 2040comprises vial adaptor subassembly 2044, onto which are placed ahydrophobic membrane 2402, above which is optionally seated a carboncloth filter 2404. Vial adaptor subassembly 2044 is connected at aforward portion thereof to a rear connection element 2406 of receptacleadaptor subassembly 2046.

A needle holding element 2408 is preferably seated within rearconnection element 2406 and supports a needle 2410. A forward portion ofneedle 2410 is preferably protected by a flexible latex needleprotection element 2412. Receptacle adaptor subassembly 2046 connects ata rearward end thereof to rear connection element 2406, enclosing needleholding element 2408 and needle protection element 2412.

The forward portion of vial adaptor subassembly 2044 as well as the rearportion of receptacle adaptor subassembly 2046 are located withinhousing element 2050.

Reference is now made to FIG. 60, which is a simplified pictorialillustration of vial adaptor subassembly 2044 which forms part ofadaptor assembly 2040 of FIG. 59 and to FIGS. 61A and 61B, which aresectional illustrations taken along respective section lines LXIA-LXIAand LXIB-LXIB in FIG. 60.

As seen in FIGS. 60-61B, vial adaptor subassembly 2044 comprises a mainbody element 2502 arranged generally about an axis 2503. Main bodyelement 2502 is preferably integrally formed and preferably injectionmolded of plastic.

Main body element 2502 is preferably side-to-side symmetric about axis2503, and preferably includes a rear portion 2504, which is generallycylindrical and terminates in a forward wall 2506. Rear portion 2504comprises a forward base section 2508, preferably having fourtransversely extending outwardly facing protrusions 2509 extendtherefrom, each protrusion being arranged at generally right angles withrespect to its neighboring protrusions.

Rearward of base section 2508 there are formed a plurality of tabs 2510each having a rectangular window 2512. Rearward of rectangular windows2512 and on an inner surface 2514 of each of tabs 2510 there arepreferably formed two radially extending inwardly facing protrusions2516 each having an inclined surface. Protrusions 2516 preferablyterminate at a forward end thereof in an inwardly facing transverselyextending protrusion 2518. Rearward of protrusions 2516, each of tabs2510 preferably includes an outwardly tapered portion 2520.

A hollow vial puncturing spike 2522 extends rearwardly from a rearwardsurface 2524 of forward wall 2506, and is surrounded by base section2508 and by tabs 2510. Rearward surface 2524 additionally includes acircular cylindrical protrusion 2525, surrounding puncturing spike 2522.Two axially extending bores 2526 and 2527 extend through vial puncturingspike 2522.

Forward of forward wall 2506 of rear portion 2504 there is formed anintermediate portion which formed of two generally rectangular surfaces2528, and includes an axial tubular portion 2530 having a bore 2531extend therethrough, bore 2531 being in fluid flow engagement with bore2526 of hollow vial puncturing spike 2522.

On the top rectangular surface 2528 and slightly recessed with respectthereto there is formed a plastic membrane support surface 2532, havingformed thereon a plurality of generally evenly distributed sphericalprotrusions 2534, which are adapted to support hydrophobic membrane 2402and prevent it from excessive inflation and from cracking. Membrane 2402is adapted to allow free passage of air to and from main body element2502, but to prevent passage of liquid and air borne particles,microorganisms and aerosol. A preferred membrane 2402 is Model VersaporR 0.2 Micron which is commercially available from Pall Corporation ofNew York, U.S.A.

A narrow bore 2537 connects membrane 2402 to bore 2531, thus allowingpressure equalization in an evacuated drug vial 2020 upon connection ofvial 2020 to the vial adaptor subassembly 2044. When fluid first passesthrough the system during drug dilution, bore 2537 irreversibly fillswith liquid, thus preventing air from escaping the system.

Prevention of the escape of air from the system is necessary for thereversible transfer of liquid from the receptacle 2012 to the vial 2020and vice versa Air movement between vial 2020 and receptacle 2012 causeschanges in pressure in the vial, thereby pushing liquid from the vialinto the receptacle.

A rim 2538 surrounding support surface 2532 is adapted to support anoptional carbon cloth filter 2404 and maintain it in a raised positionabove and spaced from membrane 2402. Carbon filter 2404 is adapted toprevent toxic vapors from escaping from main body element 2502, thusprotecting users. A preferred carbon cloth filter 2404 is Model No.Zorflex EMI which is commercially available from Charcoal ClothInternational Ltd. of Houghton-le-Spring, England.

Rectangular surfaces 2528 of the intermediate portion terminate at aforward end thereof in a forward facing cylindrical portion 2548, havinga bore 2550 extend therethrough. Preferably, bore 2550 is a continuationof tubular portion 2530 of the intermediate portion.

It is appreciated that the functionalities of membrane 2402 and carboncloth filter 2404, to allow free passage of air into the drug mixingsystem while preventing passage thereinto of liquid and air-borneparticles, microorganisms and aerosol and preventing toxic vapors fromescaping from the drug mixing system, may be incorporated, using similarelements, into any receptacle adaptor subassembly 2046.

Reference is now made to FIG. 62, which is a simplified pictorialillustration of receptacle adaptor subassembly 2046 which forms part ofthe adaptor assembly 2040 of FIG. 59 and to FIGS. 63A and 63B, which aresectional illustrations taken along respective section lines LXIIA-LXIIAand LXIIIB-LXIIIB in FIG. 62.

As seen in FIGS. 62-63B, receptacle adaptor subassembly 2046 includes amain body element 2600 which is arranged generally about an axis 2601.Main body element 2600 is preferably integrally formed of plastic, andis preferably side-to-side symmetric about axis 2601. Main body element2600 preferably includes a generally cylindrical base portion 2602terminating in a rear portion 2604.

Top and bottom generally concave wall portions 2606 are formed at aforward end of base portion 2602, each wall portion 2606 defining on anouter surface thereof an outwardly facing axially extending rib 2608,which extends from a forwardmost end of each of wall portions 2606 andalong base portion 2602.

A connection surface 2610 extending transversely from side surfaces 2612of base portion 2602 connects an outwardly extending arm 2614 to eachside surface 2612. Each arm 2614 preferably has a generally square rearportion 2616, formed rearwardly of connection surface 2610, and has aradially extending outwardly facing protrusion 2618 formed thereon.Protrusion 2618 preferably extends onto an outer surface of a generallyrectangular forward portion 2620 of each of arms 2614, which extendsforwardly of connection surface 2610.

An inwardly facing generally triangular tooth 2622 is formed adjacent atop end of each of forward portions 2620. Each tooth 2622 preferablyincludes a forwardly facing inclined surface 2624 and a rearwardlyfacing engagement surface 2626.

Rear portion 2604 preferably includes a transversely extending generallycircular portion 2630 which forms a base for ribs 2608 and whichterminates at a rear end thereof in an axially extending generallycylindrical wall portion 2632.

Wall portion 2632 preferably defines on a top and bottom surface thereofa small generally rectangular window 2634, and two forwardly facingslots 2636 which are formed on either side of window 2634. Two generallysymmetric side-facing tabs 2638 are formed on side surfaces 2640 of wallportion 2632, each tab 2638 being formed forwardly of a generallyrectangular forwardly facing slot 2642.

Rear connection element 2406 preferably includes a forward disk 2652defining a central bore 2654. Disk 2652 preferably functions as aterminating wall for a forward facing cylindrical portion 2656. Rearwardof disk 2652 there is preferably formed a rear portion 2658, having anarrow bore 2660 extend therethrough. Bore 2660 preferably widens towardthe rear end of rear portion 2658, thus enabling rear portion 2658 toconnect to an appropriate port. Preferably, two generally symmetric tabs2662 are formed on top and bottom surfaces of rear portion 2658.Cylindrical portion 2656 preferably has an outer circumference that isslightly smaller than that of wall portion 2632, and is located therein.

Needle holding element 2408 preferably supports needle 2410 on agenerally circular disk portion 2672. Needle 2410 extends axiallythrough base portion 2602 of main body element 2600 and through bore2660 of rear connection element 2650. Disk portion 2672 is preferablyseated in cylindrical portion 2656, and is locked into cylindricalportion 2656 by portion 2630.

Reference is now made to FIGS. 64A and 64B, which are simplifiedpictorial illustrations of the housing element 2050 which forms part ofthe adaptor assembly 2040 of FIG. 59 in closed and open orientations,respectively.

As seen in FIGS. 64A and 64B, housing element 2050 is preferablyintegrally formed about an axis 2700 and includes a top housing portion2701 and a bottom housing portion 2702. Preferably, housing portions2701 and 2702 are side-to-side symmetric about axis 2700. Preferably,each of housing portions 2701 and 2702 includes a semi-cylindricalforward portion 2704 and a semi-cylindrical rearward portion 2706.

Top and bottom housing portions 2701 and 2702 each include an inwardlyrecessed portion 2708 including a generally central elongate protrusion2710.

Top housing portion 2701 includes at forward and rearward ends thereofoutwardly extending fingers 2722 terminating in a generally triangularteeth 2724 which include inclined outwardly facing surfaces 2726 andengagement surfaces 2728. Bottom housing portion 2702 preferablyincludes at forward and rearward ends thereof two generally rectangularwindows 2730 which are placed generally below fingers 2722 and areadapted to engage engagement surfaces 2728 of fingers 2722 when housingelement 2050 is assembled.

An inner surface 2734 of housing element 2050 preferably includes at arearward end thereof a circumferential recess 2736 which is adapted toengage protrusions 2509 of rear portion 2504 of vial adaptor subassembly2044. An outer surface of housing element 2050 which lies above recess2736 preferably includes an outwardly facing protrusion 2740 whichprotrudes out of cylindrical rearward portion 2706.

Reference is now made to FIG. 65, which is a simplified assembledpictorial illustration of the adaptor assembly 2040 of FIG. 59 and toFIGS. 66A and 66B, which are sectional illustrations taken alongrespective section lines LXVIA-LXVIA and LXVIB-LXVIB in FIG. 65.

As seen in FIGS. 65-66B, rear portion 2504 of vial adaptor subassembly2044 extends from a rear portion of housing element 2050. Vialpuncturing spike 2522 preferably extends out of housing element 2050,and is accessible for connection of vial 2020 or of vial 2026 (FIG. 54B)thereto.

Preferably, circumferential recess 2736 of inner surface 2734 of housingelement 2050 engages protrusions 2509 of rear portion 2504 of vialadaptor subassembly 2044. Preferably, forward facing cylindrical portion2548 engages rear portion 2658 of rear connection element 2406. A rearend of needle 2410 at least partially extends through bore 2660 andthrough bore 2550 such that bore 2550 is in fluid flow communicationwith needle 2410 of receptacle adaptor subassembly 2046.

A forward portion of main body element 2600 of receptacle adaptorsubassembly 2046 preferably extends from a forward portion of housingelement 2050 of adaptor assembly 2040, and surrounds needle 2410enclosed in needle protection element 2412. Main body element 2600including needle 2410 and needle protection cover 2412 is preferablyaccessible for connection of spike port adaptor element 2010 (FIGS.57-58) thereto.

Housing element 2050 is preferably assembled, such that top housingportion 2701 and bottom housing portion 2702 are connected by engagementof engagement surfaces 2728 of teeth 2724 of top housing portion 2701and windows 2730 of bottom housing portion 2702.

Reference is now made to FIGS. 67A and 67B, which are sectionalillustrations of the drug mixing system of FIG. 54B during attachment ofvial 2020 to the vial adaptor subassembly 2044 of adaptor assembly 2040of FIG. 65.

Vial 2026 and vial head adaptor element 2030 joined thereto (FIG. 54C)or vial 2020 is preferably pushed into engagement with vial puncturingspike 2522 of vial adaptor subassembly 2044.

Typically, vial puncturing spike 2522 of vial adaptor subassembly 2044punctures septum 2024 located inside top portion 2022 of vial 2020, thusenabling fluid flow between the main body of vial 2020 and bore 2550 ofcylindrical portion 2548 of main body element 2502 of vial adaptorsubassembly 2044. Preferably, puncturing of septum 2024 releases anyvacuum in vial 2020 by entrance of air into vial 2020 through optionalcarbon cloth filter 2404 (FIG. 61A) and membrane 2402 (FIG. 61A).

Engagement between vial adaptor subassembly 2044 and vial 2010 ispreferably maintained by snap engagement of protrusions 2516 and 2518 ofrear portion 2504 of main body element 2600 with neck portion 2023 ofvial 2020. The engagement of protrusions 2516 and 2518 with neck portion2023 ensures that vial adaptor subassembly 2044 is latched onto vial2020 and cannot be removed therefrom. Tabs 2510 and outwardly taperedportions 2520 generally surround top portion 2022 and neck portion 2023of vial 2020.

At this stage, the main body of vial 2020 is in fluid flow communicationwith needle 2410 via vial puncturing spike 2522, bore 2550 ofcylindrical portion 2548 and bore 2660 of cylindrical portion 2658.

Reference is now made to FIG. 68, which is a sectional illustration ofthe drug mixing system of FIG. 54D-54G during attachment of thereceptacle port adaptor element 2010 and receptacle 2012 of FIG. 54A tothe receptacle adaptor subassembly 2046 of adaptor assembly 2040 of FIG.67, having vial 2020 attached thereto.

As seen in FIG. 68, spike port adaptor element 2010, having receptacle2012 joined thereto, is connected to receptacle adaptor subassembly 2046of adaptor assembly 2040.

Spike 2308 is preferably previously inserted into spike port 2011 ofreceptacle 2012, such that bore 2310 of spike element 2306 engages fluidcontent of receptacle 2012. Connection port 2318 of spike port adaptorelement 2010 engages wall portions 2606 and base portion 2602 of mainbody element 2600 of receptacle adaptor subassembly 2046.

Connection port 2318 is preferably locked into connection withreceptacle adaptor subassembly 2046 by engagement of engagement surfaces2626 of forward portions 2620 of arms 2614 and a rearward facing wallportion of connection port 2318.

Preferably, needle 2410 punctures needle protection cover 2412 andseptum 2320, resulting in partial collapse of the needle protectioncover. At this stage, receptacle 2012 is in fluid flow communicationwith the main body of vial 2020 via bore 2310 of spike 2308 of spikeport adaptor element 2010, needle 2410, bore 2660, bore 2550 ofcylindrical portion 2548, bore 2531 of tubular portion 2530 and vialpuncturing spike 2522.

Reference is now made to FIG. 69, which is a sectional illustration ofthe drug mixing system of FIGS. 54H and 68 during disconnection of thespike port adaptor element 2010 and receptacle 2012 from the receptacleadaptor subassembly 2046 of adaptor assembly 2040 of FIG. 67.

As shown in FIG. 69, spike port adaptor element 2010 and receptacle 2012joined thereto are disconnected from receptacle adaptor subassembly 2046of adaptor assembly 2040. Typically, spike port adaptor element 2010 isdisconnected from receptacle adaptor subassembly 2046 by slightlypushing arms 2614 extending from side surfaces 2612 of base portion2602, causing teeth 2620 to move outward and release the rearward facingwall portion of connection port 2318, thus disconnecting the connectionport. Typically, needle 2410 is released from connection port 2318, andneedle protection cover 2412 is deployed and once again fully enclosesneedle 2410, thus sealing it to prevent leakage.

Reference is now made to FIG. 70 which is a simplified exploded viewillustration of a drug mixing system constructed and operative inaccordance with a further preferred embodiment of the present invention.The embodiment of FIG. 70 is a modification of the embodiments of FIGS.31A-53 and 54A-69. Accordingly, for the sake of conciseness, it isdescribed hereinbelow in somewhat abbreviated form with reference toFIGS. 71-78.

In this embodiment the drug vial is enclosed in a protective housingused during storage and dilution, thereby preventing spills in case ofbreakage.

As seen with particular clarity in FIG. 70, the drug mixing systemcomprises a vial adaptor subassembly 3000, which preferably comprises anexternally threaded vial support element 3010, into which is placed avial 3020.

A vial puncturing cover assembly 3030 comprises an internally threadedcovering element 3032, which connects at a forward end thereof to theexternally threaded portion of vial support element 3010. At a top endthereof, covering element 3032 engages a vial puncturing spike element3034, which supports a hydrophobic membrane 3036.

Vial puncturing cover assembly 3030 connects at a forward end thereof toa connection port of a receptacle adaptor subassembly 3040, which isadapted to engage a spike port receptacle adaptor element 3050. Spikeport receptacle adaptor element 3050 is preferably inserted into areceptacle port 3051 of a receptacle 3052.

Alternatively, vial puncturing cover assembly 3030 may connect at aforward end thereof to a vial port 3080 of a stopcock 3082, and theconnection port of receptacle port adaptor assembly 3040 connects to areceptacle port 3084 of stopcock 3082. When this option is used, asyringe port 3086 of stopcock 3082 preferably engages a luer fittedsyringe.

It is appreciated that vial 3020 may be identical to either of vials2020 and 2026, and that receptacle 3052 may be identical to receptacle2012, described hereinabove with reference to FIGS. 54A-54C.

Receptacle adaptor subassembly 3040 may be identical to receptacleadaptor subassembly 2046, described hereinabove with reference to FIGS.62-63B.

Spike port adaptor element 3050 may be identical to spike port adaptorelement 2010, described hereinabove with reference to FIGS. 57-58.

Reference is now made to FIG. 71 which is a simplified pictorialillustration of a vial support element 3010 which forms part of vialadaptor subassembly 3000 of the drug mixing system of FIG. 70 and toFIGS. 72A and 72B which are, respectively, a sectional illustration anda pictorial sectional illustration taken along section lines LXXII-LXXIIin FIG. 71.

Vial support element 3010 comprises a generally cylindrical body element3100 arranged generally about an axis 3101. Body element 3100 ispreferably integrally formed and preferably is generally side-to-sidesymmetric about axis 3101.

Body element 3100 preferably includes a top portion 3102, which isexternally threaded and which is separated from a bottom portion 3104 byan outwardly facing circumferential protrusion 3106. Four axiallyextending outwardly facing protrusions 3108 are preferably formed onbottom portion 3104, each protrusion 3108 being arranged at generallyright angles with respect to its neighboring protrusions.

Body element 3100 preferably terminates in a transversely extending basewall portion 3110, which includes a central spherical protrusion 3112which is adapted to center vial 3020 in vial support element 3010.

As seen with particular clarity in FIG. 72B, an inner surface 3114 ofbody element 3100 may optionally include a plurality of axiallyextending inwardly facing generally rectangular protrusions 3116, whichare operative to adapt vial support element 3010 to support a smallervial. Different body elements 3100, molded with protrusions 3116 ofdifferent sizes, may be used for different vial sizes. Similarly, basewall portion 3110 may optionally be molded at various heights withrespect to bottom portion 3104, thus enabling different vial supportelements 3010 to support vials of different heights.

Reference is now made to FIG. 73, which is a simplified pictorialillustration of vial support element 3010 of FIGS. 71-72B containing avial 3020 and to FIG. 74, which is a sectional illustration taken alongsection lines LXXIV-LXXIV in FIG. 73.

As seen in FIGS. 73 and 74, vial 3020 is placed within vial supportelement 3010, such that top portion 3022, septum 3024 and at least partof neck portion 3023 extend above the vial support element and areaccessible to a user.

A base of vial 3020 is preferably seated on base wall portion 3110 andengages spherical protrusion 3112.

Reference is now made to FIGS. 75A and 75B, which are simplifiedpictorial illustrations of vial puncturing cover assembly 3030 whichforms part of the vial adaptor subassembly 3000 of FIG. 70 and to FIG.76 which is a sectional illustration taken along section linesLXXVI-LXXVI in FIG. 75A.

Vial puncturing cover assembly 3030 includes covering element 3032,which comprises a generally cylindrical main body portion 3202 arrangedgenerally about an axis 3203.

Main body portion 3202 is preferably internally threaded and is adaptedto engage the externally threaded top portion 3102 of vial supportelement 3010. Four axially extending outwardly facing protrusions 3204are preferably formed on an outer surface 3205 of main body portion3202, each protrusion 3204 being arranged at generally right angles withrespect to its neighboring protrusions. An outwardly facing radiallyextending wall portion 3206 extends from a bottom end of main bodyportion 3202.

Main body portion 3202 terminates in a wall portion 3208, whichpreferably extends transversely with respect to axis 3203 and includes agenerally round aperture 3210. An inner surface 3212 of wall portion3208 preferably includes two semi-circular tracks 3214.

Vial puncturing spike element 3034 preferably includes a vial puncturingspike 3220 extending through aperture 3210 of wall portion 3208. Vialpuncturing spike 3220 preferably has two axial bores 3222 and 3224extending therethrough.

Preferably membrane 3036 is in fluid flow engagement with cover element3032 via bore 3224 of vial puncturing spike 3220.

Spike 3220 preferably extends forwardly from a generally circular wallportion 3226, which engages a top surface of wall portion 3208. Fourgenerally rectangular wall portions 3228 extend radially from spike3220, each wall portion 3228 being arranged at generally right angleswith respect to its neighboring wall portions.

Wall portions 3228 preferably define at top surfaces thereof fourspherical protrusions 3230, which engage tracks 3214 and are adapted tolock vial puncturing spike element 3034 with respect to covering element3032.

A generally cylindrical portion 3232, including an axial bore 3234,preferably extends rearwardly from wall portion 3226. Cylindricalportion 3232 is preferably adapted to engage rear portion 3658 ofreceptacle adaptor subassembly 3040.

A second generally cylindrical portion 3236 preferably extendsrearwardly of wall portion 3226 and adjacent cylindrical portion 3232.Portion 3236 preferably defines a seat 3238 which is adapted to supportunidirectional breathing membrane 3036 and prevent it from excessiveinflation and from cracking. Membrane 3036 is adapted to allow freepassage of air into the main body element 3032, but prevent passagetherethrough of liquid and air-borne particles, microorganisms andaerosol. A preferred membrane 3036 is Model Versapor R 0.2 Micron whichis commercially available from Pall Corporation of New York, U.S.A.

Reference is now made to FIG. 77, which is a simplified assembledpictorial illustration of the vial adaptor subassembly 3000 of FIG. 70and to FIG. 78, which is a sectional illustration taken along sectionlines LXXVIII-LXXVIII in FIG. 77.

As seen in FIGS. 77 and 78, vial puncturing cover assembly 3030threadably engages vial support element 3010, thus enclosing thereinvial 3020.

The threaded engagement between vial support element 3010 and vialpuncturing cover element 3032 causes puncturing spike 3220 to be pushedinto engagement with vial 3020.

Typically, vial puncturing spike 3220 of vial puncturing cover element3030 punctures septum 3024 located inside top portion 3022 of vial 3020,thus enabling fluid flow between the main body of vial 3020 and bore3234 of cylindrical portion 3232 via bore 3222 of puncturing spike 3220.Preferably, puncturing of septum 3024 releases any vacuum in vial 3020.

Reference is now made to FIG. 79, which is a pictorial illustration ofthe vial adaptor subassembly 3000 of FIG. 77 when assembled toreceptacle adaptor subassembly 3040 thus forming an adaptor assembly inaccordance with a preferred embodiment of the present invention, and toFIG. 80, which is a sectional illustration taken along section linesLXXX-LXXX in FIG. 79.

As seen in FIGS. 79 and 80, cylindrical portion 3232 of vial coverelement 3030 engages rear portion 3658 of receptacle adaptor subassembly3040. A rear end of needle 3410 at least partially extends through bore3660 and through bore 3234 such that bore 3234 is in fluid flowcommunication with needle 3410 of receptacle adaptor subassembly 3040.Due to fluid flow communication between bore 3234 and the main body ofvial 3020, needle 3410 is in fluid flow communication with vial 3020.

A forward portion of main body element 3414 of receptacle adaptorsubassembly 3040 preferably surrounds needle 3410 enclosed in needleprotection element 3412. Main body element 3600 including needle 3410and needle protection cover 3412 is preferably accessible for connectionof spike port adaptor element 3050 thereto.

It is appreciated that cylindrical portion 3232 of vial cover element3030 may alternatively engage a stopcock 3052, which additionallyengages receptacle adaptor subassembly 3040 and a syringe as describedhereinabove with reference to FIGS. 31A-53. In such a case, the methodof use of the system would be similar to that described in FIGS.31A-31L.

Reference is now made to FIG. 81, which is a pictorial illustration ofvial adaptor subassembly 3000 connected to receptacle adaptorsubassembly 3040 of FIG. 79 when connected to a spike port adaptorelement 3050 and receptacle 3052 and to FIG. 82, which is a sectionalillustration taken along section lines LXXXII-LXXXII in FIG. 81.

As seen in FIGS. 81 and 82, spike port adaptor element 3050, havingreceptacle 3052 joined thereto, is connected to receptacle adaptorsubassembly 3040.

A spike 3308 is preferably previously inserted into spike port 3051 ofreceptacle 3052, such that a bore 3310 of a spike element 3306 engagesfluid content of receptacle 3052. A connection port 3318 of spike portadaptor element 3050 engages wall portions 3606 and base portion 3602 ofmain body element 3414 of receptacle adaptor subassembly 3040.

Connection port 3318 is preferably locked into connection withreceptacle adaptor subassembly 3040 by engagement of engagement surfaces3626 of forward portions 3620 of arms 3614 and a rearward facing wallportion of connection port 3318.

Preferably, needle 3410 punctures needle protection cover 3412 andseptum 3320, resulting in partial collapse of the needle protectioncover. At this stage, receptacle 3052 is in fluid flow communicationwith the main body of vial 3020 via bore 3310 of spike 3308 of spikeport adaptor element 3050, needle 3410, bore 3660, bore 3234 ofcylindrical portion 3232 and vial puncturing spike 3220.

Reference is now made to FIG. 83, which is a simplified exploded viewillustration of a drug mixing system constructed and operative inaccordance with a still further preferred embodiment of the presentinvention. The embodiment of FIG. 83 is a modification of the embodimentof FIGS. 54A-69. Accordingly, for the sake of conciseness, it isdescribed hereinbelow in somewhat abbreviated form with reference toFIGS. 84-92.

As seen with particular clarity in FIG. 83, the drug mixing systemcomprises a receptacle adaptor subassembly 4000 which preferablycomprises a receptacle adaptor housing element 4010. Receptacle adaptorhousing element 4010 preferably engages a receptacle adaptor needleassembly 4020. Receptacle adaptor subassembly 4000 preferably engages aport such as a receptacle port 4031 of a receptacle 4032.

Receptacle adaptor needle assembly 4020 connects at a rearward endthereof to a connection port of a vial adaptor subassembly 4040, whichis adapted to engage a vial 4050.

It is appreciated that vial 4050 may be identical to either of vials2020 and 2026, and receptacle 4032 may be identical to receptacle 2032,described hereinabove with reference to FIGS. 54A-54C.

Vial adaptor subassembly 4040 may be identical to vial adaptorsubassembly 2046, described hereinabove with reference to FIGS. 60-61B.

Receptacle port 4031 may be identical receptacle port 2031, describedhereinabove. It is appreciated that receptacle adaptor subassembly 4000may engage a spike port adaptor element such as spike port adaptorelement 2030 described hereinabove with reference to FIGS. 57-58.

Reference is now made to FIG. 84, which is a simplified pictorialillustration of receptacle adaptor housing element 4010 which forms partof the drug mixing system of FIG. 83 and to FIGS. 85A and 85B, which aresectional illustrations taken along section lines LXXXVA-LXXXVA andLXXXVB-LXXXVB in FIG. 84.

Receptacle adaptor housing element 4010 comprises a body element 4100,arranged generally about an axis 4101. Body element 4100 comprises atube of generally rectangular cross-section, is preferably integrallyformed and preferably is generally side-to-side symmetric about axis4101.

Body element 4100 preferably includes a rear portion 4102 which isformed with ribbed grip regions 4104 on an outer surface 4106. Twoelongate windows 4108 are preferably formed on top and bottom surfacesof rear portion 4102.

A forward portion 4110 of body element 4100 has a slightly smaller outercircumference than that of rear portion 4102, and includes a generallyrectangular window 4112 on each of the surfaces thereof. Forward portion4110 preferably sealingly accommodates a septum 4114 in a seat 4116.

Four axially extending tabs 4118 extend forwardly of forward portion4110, each tab 4118 being arranged at generally right angles withrespect to its neighboring tabs. Each tab 4118 preferably includes andan inwardly facing tooth 4120 and preferably terminates in an outwardlytapered portion 4122.

Reference is now made to FIG. 86, which is a simplified pictorialillustration of receptacle adaptor needle assembly 4020 which forms partof the drug mixing system of FIG. 83 and to FIGS. 87A and 87B, which aresectional illustrations taken along section lines LXXXVIIA-LXXXVIIA andLXXXVIIB-LXXXVIIB in FIG. 86.

Receptacle adaptor needle assembly 4020 comprises a generallycylindrical body element 4200, arranged generally about an axis 4201.Body element 4200 is preferably integrally formed and preferably isgenerally side-to-side symmetric about axis 4201.

Body element 4200 preferably includes a rear connection port 4202 whichis separated from a forward portion 4204 by a circumferential outwardlyextending protrusion 4206. Protrusion 4206 is adapted to limit theextent to which receptacle adaptor needle assembly 4020 is inserted intoreceptacle adaptor housing element 4010.

Forward portion 4204 preferably terminates in a forward wall portion4205 from which extends a cylindrical portion 4210 having an outercircumference which is slightly larger than that of forward portion4204. Cylindrical portion 4210 preferably has formed thereon fouraxially extending protrusions 4212, each protrusion 4212 being arrangedat generally right angles with respect to its neighboring protrusions.

Two outwardly extending arms 4214 are formed at a forward end ofcylindrical portion 4210, each arm 4214 being generally across from theother arm. Protrusions 4212 and arms 4214 are preferably rotationallyoffset from one another about axis 4201. Each arm 4214 preferablydefines at a forward most end thereof a generally triangular tooth 4216including an engagement surface 4218.

A hollow needle 4220 is preferably sealingly mounted in a cylindricalportion 4222 which is formed within cylindrical portion 4210 ofreceptacle adaptor needle assembly 4020.

Reference is now made to FIG. 88, which is a simplified assembledpictorial illustration of the receptacle adaptor subassembly 4000 ofFIG. 83 and to FIGS. 89A and 89B, which are sectional illustrationstaken along section lines LXXXIXA-LXXXIXA and LXXXIXB-LXXXIXB in FIG.88.

As seen in FIGS. 88-89B, cylindrical portion 4210 of receptacle adaptorneedle assembly 4020 preferably engages a rearwardmost portion of rearportion 4102 of receptacle adaptor housing element 4010. Teeth 4216 ofarms 4214 of cylindrical portion 4210 preferably extend through windows4108 and maintain receptacle adaptor needle assembly 4020 locked inreceptacle adaptor housing element 4010.

It is appreciated that a user may push receptacle adaptor needleassembly 4020 inward with respect to receptacle adaptor housing element4010. Such inward motion of receptacle adaptor needle assembly 4020 islimited by protrusion 4206.

Reference is now made to FIG. 90, which is a pictorial illustration ofthe receptacle adaptor subassembly 4000 of FIG. 88 when assembled to avial adaptor subassembly 4040 and to port 4031 of receptacle 4032, priorto insertion of needle 4220 into the receptacle port 4031 and to FIG.91, which is a sectional illustration taken along section lines XCI-XCIin FIG. 90.

Vial 4050 is preferably pushed into engagement with a vial puncturingspike 4522 of vial adaptor subassembly 4040.

Typically, vial puncturing spike 4522 of vial adaptor subassembly 4050punctures a septum 4014 located inside a top portion 4012 of vial 4050,thus enabling fluid flow between the main body of vial 4050 and a bore4550 of a cylindrical portion 4548 of main body element 4502 of vialadaptor subassembly 4050. Preferably, puncturing of septum 4014 releasesany vacuum in vial 4050 by entrance of air into vial 4050 through acarbon filter 4404 and a membrane 4402.

Engagement between vial adaptor subassembly 4040 and vial 4050 ispreferably maintained by snap engagement of protrusions 4516 and 4518 ofrear portion 4504 of main body element 4502 with neck portion 4013 ofvial 4050. The engagement of protrusions 4516 and 4518 with neck portion4013 ensures that vial adaptor subassembly 4040 is latched onto vial4050 and cannot be removed therefrom. Tabs 4510 and outwardly taperedportions 4520 generally surround top portion 4012 and neck portion 4013of vial 4050.

Cylindrical portion 4548 preferably engages connection port 4202 ofreceptacle adaptor needle assembly 4020, such that needle 4220 is influid flow communication with vial 4050 via forward portion 4204, bore4550 of cylindrical portion 4548 and vial puncturing spike 4522. Thesharpened tip of needle 4220 preferably partially extends through septum4114.

Teeth 4120 of arms 4118 preferably engage receptacle port 4031 ofreceptacle 4032, or may alternatively engage any other suitable portsuch as a spike port adaptor element 4030 as described hereinabove.

Reference is now made to FIG. 92, which is a pictorial illustration ofthe receptacle adaptor subassembly 4000 of FIG. 88 when assembled to avial adaptor subassembly 4040 and to port 4031 of receptacle 4032,following insertion of needle 4220 into receptacle port 4031 and to FIG.93, which is a sectional illustration taken along section linesXCIII-XCIII in FIG. 92.

As seen in FIGS. 92 and 93, a user preferably pushes receptacle adaptorneedle assembly 4020 inward, such that needle 4220 pierces septum 4114,resulting in fluid flow communication between receptacle 4032 and vial4050.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the present inventionincludes both combinations and subcombinations of various featuresdescribed hereinabove as well as modifications thereof which would occurto persons skilled in the art upon reading the foregoing specificationand which are not in the prior art.

The invention claimed is:
 1. A drug mixing system comprising: at leastone receptacle port adaptor adapted to be inserted into a port of afluid receptacle; at least one vial adaptor adapted for connection to avial containing a drug; and at least one syringe adaptor adapted to beattached to a syringe and to at least one of said at least onereceptacle port adaptor and said at least one vial adaptor, said atleast one syringe adaptor comprising: a septa housing; at least twosepta enclosed in said septa housing, said at least two septa defining aspace therebetween; and a needle, including a tip located in said spacewhen said syringe adaptor is not connected to said at least one of saidat least one receptacle port adaptor and said at least one vial adaptor.2. A drug mixing system according to claim 1 and also comprising amembrane vent operative to vent at least one of said at least onereceptacle port adaptor, said at least one syringe adaptor and said atleast one vial adaptor to the atmosphere.
 3. A drug mixing systemaccording to claim 2 and wherein said membrane vent includes anadsorbent.
 4. A drug mixing system according to claim 3 and wherein saidadsorbent is a carbon cloth.
 5. A drug mixing system according to claim2 and wherein said membrane vent comprises a hydrophobic membrane.
 6. Adrug mixing system according to claim 1 and wherein said receptacle portadaptor, said syringe adaptor and said vial adaptor are integrallyformed.
 7. A drug mixing system according to claim 1 and wherein said atleast one vial adaptor also comprises a protective vial housingoperative to prevent the spread of possibly harmful contents of saidvial in the event of breakage of said vial.
 8. A drug mixing systemaccording to claim 1 and wherein said fluid receptacle includes a spikeport and said at least one receptacle port adaptor includes a spike portadaptor.
 9. A drug mixing system according to claim 1 and wherein saidfluid receptacle includes a needle port and said at least one receptacleport adaptor includes a needle port adaptor.
 10. A drug mixing systemaccording to claim 9 and wherein said needle port adaptor includes alocking mechanism, operative to lock said needle port adaptor to saidneedle port.
 11. A drug mixing system according to claim 9 and whereinsaid needle port adaptor includes a needle, said needle of said needleport adaptor being protected by a needle protector.
 12. A drug mixingsystem according to claim 11, wherein said needle of said needle portadaptor is movable between a protected resting position and an activepiercing position upon connection of said needle port adaptor to saidneedle port.
 13. A drug mixing system according to claim 11 and whereinsaid needle protector comprises a latex needle cover.
 14. A drug mixingsystem according to claim 1 and also comprising a vial head adaptoradapted for connection between said vial adaptor and said vial.
 15. Adrug mixing system according to claim 1 and wherein said at least onereceptacle port adaptor and said fluid receptacle are adapted to beconnected to an intravenous cannula on a patient via an intravenousinfusion set.
 16. A drug mixing system according to claim 1 and whereinsaid at least one syringe adaptor and said syringe are adapted to beconnected to an intravenous cannula on a patient via an intravenousinfusion set using an infusion set adaptor.
 17. A drug mixing systemaccording to claim 1 and wherein said at least one syringe adaptor iscovered by a syringe adaptor cover element.
 18. A drug mixing systemaccording to claim 1 and wherein said septa housing is movable relativeto said needle, thereby to expose said tip.
 19. A drug mixing systemaccording to claim 1 and also comprising a spring associated with saidsepta housing and wherein said septa housing is biased by said spring toa protective position in which said needle tip is protected.
 20. A drugmixing system according to claim 1 and wherein at least a portion ofsaid needle is protected by a needle protector.